Adjustable intraocular lenses and methods of post-operatively adjusting intraocular lenses

ABSTRACT

Disclosed are adjustable accommodating intraocular lenses and methods of adjusting accommodating intraocular lenses post-operatively. In one embodiment, an adjustable accommodating intraocular lens comprises an optic portion and a peripheral portion. At least one of the optic portion and the peripheral portion can be made in part of a composite material comprising an energy absorbing constituent and a plurality of expandable components. At least one of a base power and a cylindricity of the optic portion can be configured to change in response to an external energy directed at the composite material.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.62/911,039 filed on Oct. 4, 2019, the entirety of which is incorporatedherein by reference.

TECHNICAL FIELD

The present disclosure relates generally to the field of intraocularlenses, and, more specifically, to adjustable intraocular lenses andmethods of adjusting intraocular lenses

BACKGROUND

A cataract is a condition involving the clouding over of the normallyclear lens of a patient's eye. Cataracts occur as a result of aging,hereditary factors, trauma, inflammation, metabolic disorders, orexposure to radiation. Age-related cataract is the most common type ofcataracts. In treating a cataract, the surgeon removes the crystallinelens matrix from the patient's lens capsule and replaces it with anintraocular lens (IOL). Traditional IOLs provide one or more selectedfocal lengths that allow the patient to have distance vision. However,after cataract surgery, patients with traditional IOLs often requireglasses or other corrective eyewear for certain activities since the eyecan no longer undertake accommodation (or change its optical power) tomaintain a clear image of an object or focus on an object as itsdistance varies.

Newer IOLs such as accommodating IOLs, allow the eye to regain at leastsome focusing ability. Accommodating IOLs (AIOLs) use forces availablein the eye to change some portion of the optical system in order torefocus the eye on distant or near targets. Examples of AIOLs arediscussed in the following U.S. patent publications: U.S. Pat. Pub. No.2018/0256315; U.S. Pat. Pub. No. 2018/0153682; and U.S. Pat. Pub. No.2017/0049561 and in the following issued U.S. Pat. Nos. 10,299,913;10,195,020; and 8,968,396, the contents of which are incorporated hereinby reference in their entireties.

Even with AIOLs, there may be a need to adjust such lensespost-operatively or after implantation within the eye of a patient. Forexample, once an AIOL is implanted within the capsular bag, anaggressive healing response by tissue within the capsular bag cansqueeze an AIOL and drive the optical power higher than initiallyanticipated. In some cases, the pre-operative biometry measurements madeon a patient's eye may be incorrect, leading to IOLs with the wrong lenspower being prescribed and implanted within the patient. Moreover, apatient's cornea or muscles within the eye may change as a result ofinjury, disease, or aging. In such cases, it may also be necessary toadjust the patient's implanted IOLs or AIOLs to account for suchchanges.

Besides lower-order aberrations (such as focusing power), higher-orderaberrations such as cylindrical astigmatism and spherical aberration arealso commonly corrected with intraocular lenses. Cylindrical astigmatismis generally developed in the cornea naturally and a large proportion ofpatients with preexisting cataracts also have some degree ofastigmatism. While toric IOLs have been used to correct astigmatism atthe time of cataract surgery, one difficulty faced by all toric lensmakers is that such lenses are rotationally asymmetric so properplacement of the lens relative to a patient's own existing aberration iscrucial. When a misplacement does occur, a patient's only recourse isoften to undergo additional surgery to correct for such a misplacement.

Therefore, a solution is needed which allows for post-implant adjustmentof IOLs or AIOLs without having to undergo additional surgery. Such asolution should not overly complicate the design of such lenses andstill allow the lenses to be cost-effectively manufactured.

SUMMARY

Disclosed herein are adjustable intraocular lenses, adjustableaccommodating intraocular lenses, and methods of adjusting intraocularlenses and accommodating intraocular lenses. In one embodiment, anadjustable accommodating intraocular lens is disclosed comprising anoptic portion comprising an anterior element and a posterior element.The anterior element can comprise an anterior optical surface. Theposterior element can comprise a posterior optical surface. Afluid-filled optic fluid chamber can be defined in between the anteriorelement and the posterior element.

The optic portion can have a base power or base spherical power. Thebase power of the optic portion can be configured to change based on aninternal fluid pressure within the fluid-filled optic fluid chamber. Thebase power of the optic portion can be configured to increase ordecrease as fluid enters or exits the optic fluid chamber. The opticportion can be configured to change shape in response to fluid enteringor exiting the optic fluid chamber. In certain embodiments, the anteriorelement of the optic portion can be configured to change shape inresponse to the fluid entering or exiting the optic fluid chamber. Inother embodiments, the posterior element of the optic portion can beconfigured to change shape in response to the fluid entering or exitingthe optic fluid chamber. In further embodiments, both the anteriorelement and the posterior element of the optic portion can be configuredto change shape in response to the fluid entering or exiting the opticfluid chamber.

The base power of the optic portion can be configured to change inresponse to the shape change undertaken by the shape-changing opticportion (e.g., the anterior element, the posterior element, or acombination thereof). The shape-changing optic portion can be configuredto change shape in response to a physiologic muscle movement (e.g.,ciliary muscle movement) undertaken by a patient when the adjustableaccommodating intraocular lens is implanted within an eye of thepatient.

In some embodiments, the adjustable accommodating intraocular lens cancomprise one or more haptics coupled to and extending from the opticportion. Each of the one or more haptics can comprise a haptic fluidchamber within the haptic. The base power of the optic portion can beconfigured to increase as fluid enters the optic fluid chamber from thehaptic fluid chamber(s). The base power of the optic portion can beconfigured to decrease as fluid exits or is drawn out of the optic fluidchamber into the haptic fluid chamber(s).

The optic fluid chamber can be in fluid communication with or fluidlyconnected to the haptic fluid chamber(s). The optic fluid chamber can bein fluid communication with a haptic fluid chamber through a pair offluid channels. The fluid channels can be conduits or passagewaysfluidly connecting the optic fluid chamber to the haptic fluid chamber.The pair of fluid channels can be spaced apart from one another. Forexample, the pair of fluid channels can be spaced apart between about0.1 mm to about 1.0 mm.

In some embodiments, the pair of fluid channels can be defined andextend through part of the optic portion. More specifically, the pair offluid channels can be defined and extend through the posterior element.

The one or more haptics can be coupled to the optic portion at ahaptic-optic interface. The one or more haptics can be coupled to theoptic portion at a reinforced portion along the optic portion. Thereinforced portion can be part of the haptic-optic interface. The pairof fluid channels can be defined or formed within part of the reinforcedportion.

In some embodiments, the adjustable accommodating intraocular lens cancomprise two haptics coupled to and extending from the optic portion.The first haptic can comprise a first haptic fluid chamber within thefirst haptic. The second haptic can comprise a second haptic fluidchamber within the second haptic. The first haptic can be coupled to theoptic portion at a first haptic-optic interface and the second hapticcan be coupled to the optic portion at a second haptic-optic interface.

In these embodiments, the optic fluid chamber can be in fluidcommunication with both the first haptic fluid chamber and the secondhaptic fluid chamber. The optic fluid chamber can be in fluidcommunication with the first haptic fluid chamber through a first pairof fluid channels. The optic fluid chamber can be in fluid communicationwith the second haptic fluid chamber through a second pair of fluidchannels.

The first pair of fluid channels can be spaced apart from one another.The first pair of fluid channels can be spaced apart between about 0.1mm to about 1.0 mm. The second pair of fluid channels can be spacedapart from one another. The second pair of fluid channels can be spacedapart between about 0.1 mm to about 1.0 mm.

The first pair of fluid channels and the second pair of fluid channelscan be defined and extend through part of the optic portion. The firstpair of fluid channels and the second pair of fluid channels can bedefined and extend through the posterior element.

The optic portion can also comprise a first reinforced portion and asecond reinforced portion substantially on opposing sides of the opticportion or substantially diametrically opposed to one another. The firstpair of fluid channels can be defined or formed within the firstreinforced portion. The second pair of fluid channels can be defined orformed within the second reinforced portion.

The first pair of fluid channels can terminate at a first pair ofapertures defined within the optic portion. The first pair of fluidchannels can terminate at a first pair of apertures defined within theposterior element. The first pair of apertures can be spaced apartbetween about 0.1 mm to about 1.0 mm. The second pair of fluid channelscan terminate at a second pair of apertures defined within the opticportion. The second pair of fluid channels can terminate at a secondpair of apertures within the posterior element. The second pair ofapertures can be spaced apart between about 0.1 mm to about 1.0 mm.

In some embodiments, the first pair of fluid channels and the secondpair of fluid channels can be positioned substantially on opposite sidesof the optic portion. The first pair of fluid channels can be positionedsubstantially diametrically opposed to the second pair of fluidchannels.

In these embodiments, the first pair of apertures and the second pair ofapertures can be positioned substantially on opposite sides of the opticportion. The first pair of apertures can be positioned substantiallydiametrically opposed to the second pair of apertures.

In some embodiments, at least one of the optic portion and theperipheral portion (e.g., the haptics) can be made in part of across-linked copolymer comprising a copolymer blend. Moreover, at leastone of the optic portion and the peripheral portion can be made in partof a composite material comprising an energy absorbing constituent, aplurality of expandable components, and a composite base material madein part of the copolymer blend. At least one of a base power and acylindricity of the optic portion can be configured to change inresponse to an external energy directed at the composite material.

In certain embodiments, the adjustable accommodating intraocular lenscan be implanted within an eye of a subject. At least one of the basepower and the cylindricity of the optic portion can be configured tochange in response to the external energy directed at the compositematerial when the adjustable accommodating intraocular lens is implantedwithin an eye of the subject.

In some embodiments, the expandable components can be expandablemicrospheres comprising a blowing agent within expandable thermoplasticshells. The blowing agent can be a branched-chain hydrocarbon. Forexample, the branched-chain hydrocarbon can be isopentane.

The thickness of the thermoplastic shells can be configured to change inresponse to the external energy directed at the composite material. Insome embodiments, the thermoplastic shells can be made in part of anacrylonitrile copolymer.

A diameter of at least one of the expandable microspheres can beconfigured to increase between about two times (2×) to about four times(4×) in response to the external energy directed at the compositematerial. A volume of at least one of the expandable microspheres can beconfigured to expand between about ten times (10×) to about fifty times(50×) in response to the external energy directed at the compositematerial.

The expandable components can comprise between about 5% to about 15%(more specifically, about 8% to about 12%) by weight of the compositematerial. For example, the expandable components can comprise about 10%by weight of the composite material.

The energy absorbing constituent can comprise between about 0.025% toabout 1.0% (or, more specifically, about 0.045% to about 0.45%) byweight of the composite material. In some embodiments, the energyabsorbing constituent can be an energy absorbing colorant. For example,a color of the energy absorbing colorant can be visually perceptible toa clinician or another medical professional when the accommodatingintraocular lens is implanted within an eye.

The energy absorbing colorant can be a dye. For example, the dye can bean azo dye. In some embodiments, the dye can be a red azo dye such asDisperse Red 1 dye. The energy absorbing colorant can also comprise apigment. For example, the pigment can be graphitized carbon black.

In some embodiments, at least one of the optic portion and theperipheral portion can be made in part of a first composite material anda second composite material. The first composite material can comprise afirst energy absorbing colorant. The second composite material cancomprise a second energy absorbing colorant. In certain embodiments, thecolor of the first energy absorbing colorant can be different from thecolor of the second energy absorbing colorant.

In addition to the copolymer blend, the composite base material canfurther comprise at least one of one or more reactive acrylic monomerdiluents, a photoinitiator, and a thermal initiator. The copolymer blendcan comprise an alkyl acrylate, a fluoro-alkyl acrylate, and aphenyl-alkyl acrylate. The composite material can remain relativelyfixed at one or more locations within the optic portion or theperipheral portion during all phases of accommodation ordisaccommodation of the intraocular lens.

As previously discussed, the base power of the adjustable accommodatingintraocular lens can be configured to change in response to an externalenergy directed at a composite material making up at least part of theadjustable accommodating intraocular lens. The base power of the opticportion can be configured to change between about ±0.05 D to about ±0.5D (e.g., more specifically, between about ±0.1 D to about ±0.2 D) inresponse to pulses of the external energy directed at the compositematerial. In some embodiments, the base power of the optic portion canbe configured to change by up to ±2.0 D in total. In other embodiments,the base power of the optic portion can be configured to change by up to±5.0 D in total.

In some embodiments, the external energy can be light energy. Theexternal energy can be light energy from a laser light. The light energycan have a wavelength between about 488 nm to about 650 nm. For example,the light energy can be green laser light having a wavelength betweenabout 520 nm to about 570 nm. As a more specific example, the lightenergy can be green laser light having a wavelength of about 532 nm.

The external energy directed or otherwise applied to the compositematerial can cause a persistent change in an optical parameter of theadjustable accommodating intraocular lens. For example, the externalenergy directed or otherwise applied to the composite material can causea persistent change in the base power of the adjustable accommodatingintraocular lens. Also, for example, the external energy directed orotherwise applied to the composite material can cause a persistentchange in the cylindricity of the optic portion of the adjustableaccommodating intraocular lens.

In some embodiments, the optic portion can be made in part of thecomposite material. In these embodiments, at least one of the base powerand the cylindricity of the optic portion can be configured to change inresponse to the external energy directed at the optic portion. Forexample, the composite material can be located along a first peripheraledge of an anterior element of the optic portion. In this example, thecomposite material can also be located along a second peripheral edgediametrically opposed to the first peripheral edge. The cylindricity ofthe anterior optical surface can be configured to change in response tothe external energy directed at the first peripheral edge and the secondperipheral edge.

Alternatively, the composite material can also be located along a firstperipheral edge along a second peripheral edge of a posterior element ofthe optic portion. The second peripheral edge can be diametricallyopposed to the first peripheral edge. The cylindricity of the posterioroptical surface can be configured to change in response to the externalenergy directed at the first peripheral edge and the second peripheraledge.

As previously discussed, the anterior element of the optic portion canbe bonded or otherwise adhered circumferentially to the posteriorelement by an adhesive layer. In some embodiments, the adhesive layercan comprise the composite material. The base power of the optic portioncan be configured to decrease in response to an external energy directedat the adhesive layer. The adhesive layer can be configured to expand inresponse to the external energy directed at the adhesive layer.Expansion of the adhesive layer can cause a volume of the optic fluidchamber within the optic portion to increase. An increase in the volumeof the optic fluid chamber can cause an internal fluid pressure withinthe optic fluid chamber to decrease, thereby causing the anteriorelement to flatten or decrease its curvature.

In other embodiments, the peripheral portion (e.g., the haptic(s)) ofthe adjustable accommodating intraocular lens can be made in part of thecomposite material. As previously discussed, the peripheral portion caninclude at least one haptic comprising a fluid-filled haptic fluidchamber in fluid communication with the optic chamber. The base power ofthe optic portion can be configured to change in response to theexternal energy directed at portions of the peripheral portion made inpart of the composite material. The external energy can cause fluid flowor fluid displacement between the fluid-filled optic chamber and thehaptic fluid chamber.

For example, the base power can be configured to change in response to achange in the volume of the haptic fluid chamber. Also, for example, thebase power of the adjustable accommodating intraocular lens can beconfigured to change in response to an interaction between theperipheral portion and a capsular environment surrounding the adjustableaccommodating intraocular lens when the lens is implanted within an eye.

More specifically, the composite material can be configured or designedas a spacer extending radially from a haptic chamber wall. The spacercan be configured to expand in response to the external energy directedat the spacer. Expansion of the spacer can result in a reduction of thevolume of the haptic fluid chamber by pushing the haptic(s) against oneor more capsular bag walls.

The composite material can also be located partly within a hapticchamber wall surrounding the haptic fluid chamber. For example, thecomposite material can be located at least partially within a channelformed along a radially inner wall of the haptic. A volume of the hapticfluid chamber can be configured to increase in response to the externalenergy directed at the composite material.

In other embodiments, the composite material can be positioned orlocated at least partially along a radially outermost portion of aradially inner wall of the haptic. A volume of the haptic fluid chambercan be configured to decrease in response to the external energydirected at the composite material. In at least some of theseembodiments, the composite material can expand into the haptic fluidchamber in response to the external energy directed at the compositematerial.

In further embodiments, a haptic of the adjustable accommodatingintraocular lens can comprise a first haptic portion and a second hapticportion. The first haptic portion and the second haptic portion can bemade in part of the composite material. A base power of the opticportion can be configured to increase in response to an external energydirected at the first haptic portion. For example, the base power of theoptic portion can be configured to increase in response to fluid flowingfrom the haptic fluid chamber to the optic fluid chamber as a result ofthe external energy directed at the first haptic portion.

Moreover, the base power of the optic portion can be configured todecrease in response to the external energy directed at the secondhaptic portion. The base power of the optic portion can be configured todecrease in response to fluid flowing from the optic fluid chamber tothe haptic fluid chamber as a result of the external energy directed atthe second haptic portion. At least one of the first haptic portion andthe second haptic portion can be located partly within a haptic chamberwall surrounding the haptic fluid chamber.

In some embodiments, the first haptic portion can be made in part of afirst composite material and the second haptic portion can be made inpart of a second composite material. The first composite material cancomprise a first energy absorbing constituent and the second compositematerial can comprise a second energy absorbing constituent. Thecomposition of the first energy absorbing constituent can be differentfrom the composition of the second energy absorbing constituent. Forexample, the first energy absorbing constituent can be an energyabsorbing dye having a first color. In this example, the second energyabsorbing constituent can be another energy absorbing dye having asecond color different from the first color.

The first haptic portion can be radially offset from the second hapticportion. In some embodiments, at least one of the first haptic portionand the second haptic portion can be oriented in a pattern such that alocation of the at least one of the first haptic portion and the secondhaptic portion along the haptic is visually perceptible to a clinicianor another medical professional.

A method of adjusting an accommodating intraocular lens is alsodisclosed. The method can comprise adjusting a base power of theaccommodating intraocular lens by directing an external energy at acomposite material within at least one of an optic portion and aperipheral portion of the accommodating intraocular lens. The compositematerial can comprise an energy absorbing constituent, a plurality ofexpandable components, and the composite base material made in part ofthe copolymer blend.

The method can further comprise adjusting the base power of theaccommodating intraocular lens when the accommodating intraocular lensis implanted within an eye of a subject. The method can further compriseadjusting the cylindricity of an optical surface of the optic portion ofthe accommodating intraocular lens by directing an external energy atthe composite material arranged at diametrically opposed peripheraledges of the optic portion.

The method can also comprise directing the external energy at thecomposite material to energize the energy absorbing constituent to causethermal energy to be transferred to the expandable components. In someembodiments, the plurality of expandable components can be expandablemicrospheres comprising a blowing agent contained within thermoplasticshells. Directing the external energy at the composite material cancause the microspheres to expand.

In some embodiments, the external energy can be light energy. Forexample, the light energy can be laser light having a wavelength betweenabout 488 nm to about 650 nm.

The method can further comprise adjusting the base power of the opticportion between about ±0.05 D to about ±0.5 D (e.g., more specifically,between about ±0.1 D to about ±0.2 D) in response to pulses of theexternal energy directed at the composite material.

The method can also comprise directing the external energy at thecomposite material to displace fluid between the optic chamber and thehaptic fluid chamber. For example, the method can comprise directing theexternal energy at the composite material to change a volume of thehaptic fluid chamber. This change in the volume of the haptic fluidchamber can result in a change in the base power of the accommodatingintraocular lens. The method can further comprise adjusting the basepower of the accommodating intraocular lens by directing the externalenergy at the composite material to cause a haptic of the lens tointeract with a capsular environment surrounding the implantedaccommodating intraocular lens.

Moreover, the method can also comprise adjusting the base power of theaccommodating intraocular lens by directing the external energy at thecomposite material to change a volume of the optic fluid chamber. Thischange in the volume of the optic fluid chamber can result in fluid flowout of the optical fluid chamber, thereby causing part of the opticportion to change shape and the base power of the lens to decrease.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a top plan view of an embodiment of an adjustableaccommodating intraocular lens.

FIGS. 1B and 1C illustrate sectional views of an embodiment of theadjustable accommodating intraocular lens.

FIG. 1D illustrates an exploded view of an embodiment of the adjustableaccommodating intraocular lens.

FIG. 2A illustrates a composite material used to make at least part ofthe adjustable accommodating intraocular lens.

FIG. 2B illustrates one embodiment of an expandable component of thecomposite material.

FIGS. 3A and 3B illustrate sectional views of an embodiment of theadjustable accommodating intraocular lens comprising an expandablespacer.

FIGS. 4A and 4B illustrate top and sectional views, respectively, ofanother embodiment of the adjustable accommodating intraocular lenscomprising the expandable spacer extending radially inward.

FIGS. 5A and 5B illustrate sectional views of another embodiment of theadjustable accommodating intraocular lens comprising an expandablespreader.

FIG. 6 illustrates a sectional view of another embodiment of theadjustable accommodating intraocular lens comprising an expandableprotuberance.

FIGS. 7A and 7B illustrate top and sectional views, respectively, ofanother embodiment of the adjustable accommodating intraocular lenscomprising both an expandable spreader and an expandable protuberance.

FIG. 8 illustrates a top plan view of another embodiment of theadjustable accommodating intraocular lens comprising both expandablespreaders and expandable protuberances implemented as discretecomponents along the haptics.

FIG. 9A illustrates a top plan view of another embodiment of theadjustable accommodating intraocular lens comprising both expandablespreaders and expandable protuberances arranged in a visuallyperceptible pattern.

FIG. 9B illustrates a sectional view of the embodiment of the adjustableaccommodating intraocular lens shown in FIG. 9A taken alongcross-section A-A.

FIG. 9C illustrates a sectional view of the embodiment of the adjustableaccommodating intraocular lens shown in FIG. 9A taken alongcross-section B-B.

FIG. 10 illustrates a sectional view of an optic portion of anotherembodiment of the adjustable accommodating intraocular lens comprisingan adhesive layer made in part of the composite material.

FIG. 11 illustrates a perspective view of another embodiment of theadjustable accommodating intraocular lens configured to exhibitcylindricity in response to an external energy directed at theadjustable accommodating intraocular lens.

DETAILED DESCRIPTION

FIG. 1A illustrates a top plan view of an embodiment of an adjustableaccommodating intraocular lens (AIOL) 100 for correcting defocusaberration, corneal astigmatism, spherical aberration, or a combinationthereof. The adjustable AIOL 100 can comprise an optic portion 102 and aperipheral portion 103 that, in this embodiment, comprises one or morehaptics 104 including a first haptic 104A and a second haptic 104Bcoupled to and extending peripherally from the optic portion 102. Theadjustable AIOL 100 is configured to be positioned within a nativecapsular bag in which a native lens has been removed.

When implanted within the native capsular bag, the optic portion 102 canbe adapted to refract light that enters the eye onto the retina. Theperipheral portion 103 (e.g., the one or more haptics 104) can beconfigured to engage the capsular bag and is adapted to deform inresponse to ciliary muscle movement (e.g., muscle relaxation, musclecontraction, or a combination thereof) in connection with capsular bagreshaping. Engagement of the peripheral portion 103 (e.g., the one ormore haptics 104) with the capsular bag will be discussed in more detailin the following sections.

FIGS. 1B and 1C illustrate sectional views of an embodiment of theadjustable AIOL 100 as taken along cross-section A-A of FIG. 1A. Asshown in FIGS. 1B and 1C, the optic portion 102 can comprise an anteriorelement 106 and a posterior element 108. A fluid-filled optic fluidchamber 110 can be defined in between the anterior element 106 and theposterior element 108.

The anterior element 106 can comprise an anterior optical surface 112and an anterior inner surface 114 opposite the anterior optical surface112. The posterior element 108 can comprise a posterior optical surface116 and a posterior inner surface 118 opposite the posterior opticalsurface 116. Any of the anterior optical surface 112, the posterioroptical surface 116, or a combination thereof can be considered andreferred to as an external optical surface. The anterior inner surface114 and the posterior inner surface 118 can face the optic fluid chamber110. At least part of the anterior inner surface 114 and at least partof the posterior inner surface 118 can serve as chamber walls of theoptic fluid chamber 110.

Each of the one or more haptics 104 can comprise a haptic fluid chamber120 within the haptic 104. For example, the first haptic 104A cancomprise a first haptic fluid chamber 120A within the first haptic 104Aand the second haptic 104B can comprise a second haptic fluid chamber120B within the second haptic 104B. The haptic fluid chamber 120 (e.g.,any of the first haptic fluid chamber 120A, the second haptic fluidchamber 120B, or a combination thereof) can be in fluid communicationwith or fluidly connected to the optic fluid chamber 110.

The optic fluid chamber 110 can be in fluid communication with the oneor more haptic fluid chambers 120 through a pair of fluid channels 122(see FIG. 1A). The fluid channels 122 can be conduits or passagewaysfluidly connecting the optic fluid chamber 110 to the haptic fluidchamber 120. The pair of fluid channels 122 can be spaced apart from oneanother. For example, the pair of fluid channels 122 can be spaced apartbetween about 0.1 mm to about 1.0 mm. In some embodiments, each of thepair of fluid channels 122 has a diameter of between about 0.4 mm toabout 0.6 mm.

In some embodiments, the pair of fluid channels 122 can be defined andextend through part of the optic portion 102. More specifically, thepair of fluid channels 122 can be defined and extend through theposterior element 108.

FIG. 1A illustrates that one or more haptics 104 of the peripheralportion 103 can be coupled to the optic portion 102 at a haptic-opticinterface 124. For example, the one or more haptics 104 can be coupledto the optic portion at a reinforced portion 126 (see FIG. 1D) along theoptic portion 102. The reinforced portion 126 can be part of thehaptic-optic interface 124. The pair of fluid channels 122 can bedefined or formed within part of the reinforced portion 126.

The optic fluid chamber 110 can be in fluid communication with the firsthaptic fluid chamber 120A through a first pair of fluid channels 122A.The optic fluid chamber 110 can also be in fluid communication with thesecond haptic fluid chamber 120B through a second pair of fluid channels122B.

The two fluid channels of the first pair of fluid channels 122A can bespaced apart from one another. The two fluid channels of the first pairof fluid channels 122A can be spaced apart from one another betweenabout 0.1 mm to about 1.0 mm. The two fluid channels of the second pairof fluid channels 122B can be spaced apart from one another. The twofluid channels of the second pair of fluid channels 122B can be spacedapart from one another between about 0.1 mm to about 1.0 mm.

In some embodiments, the first pair of fluid channels 122A and thesecond pair of fluid channels 122B can be positioned substantially onopposite sides of the optic portion 102. The first pair of fluidchannels 122A can be positioned substantially diametrically opposed tothe second pair of fluid channels 122B.

The first pair of fluid channels 122A and the second pair of fluidchannels 122B can be defined or extend through part of the optic portion102. The first pair of fluid channels 122A and the second pair of fluidchannels 122B can be defined or extend through the posterior element108.

A design with two fluid channels 122 rather than one channel helpsmaintain dimensional stability during assembly, which can be importantwhen assembling flexible and thin components. Additionally, it wasobserved through experimentation that a design with two fluid channels122 provided better optical quality than certain one-channel designsthroughout the range of accommodation. The additional stiffness of thetwo fluid channel design results in less deflection due to pressurechanges in the fluid channels.

As shown in FIG. 1D, the optic portion 102 can comprise a firstreinforced portion 126A and a second reinforced portion 126Bsubstantially on opposing sides of the optic portion 102 orsubstantially diametrically opposed to one another. The first pair offluid channels 122A can be defined or formed within the first reinforcedportion 126A. The second pair of fluid channels 122B can be defined orformed within the second reinforced portion 126B.

The pair of fluid channels 122 (e.g., any of the first pair of fluidchannels 122A or the second pair of fluid channels 122B) can have a pairof inner apertures 128 disposed at one end of the fluid channels 122 andanother pair of outer apertures 130 disposed at the other end of thefluid channels 122. The pair of inner apertures 128 can be defined orformed on part of the posterior element 108. As shown in FIGS. 1B-1D,the inner apertures 128 can be defined or formed on part of a raisedinner surface 132 of the posterior element 108. In some embodiments, theraised inner surface 132 can be a sloped or beveled surface.

The pair of outer apertures 130 can be defined or formed on part of aprotruding outer surface 134 of the posterior element 108. Theprotruding outer surface 134 can be part of the reinforced portion 126.The protruding outer surface 134 can also be part of the haptic-opticinterface 124.

For example, FIG. 1D shows a pair of inner apertures 128 disposed at oneend of the first pair of fluid channels 122A and defined along theraised inner surface 132 of the posterior element 108. FIG. 1D alsoshows a pair of outer apertures 130 serving as ends of the second pairof fluid channels 122B and defined along the protruding outer surface134 of the posterior element 108. The pair of outer apertures 130 of thefirst pair of fluid channels 122A and the pair of inner apertures 128 ofthe second pair of fluid channels 122B are obscured in FIG. 1D.

The two apertures of the pair of inner apertures 128 can be spaced apartfrom one another between about 0.1 mm to about 1.0 mm. The two aperturesof the pair of outer apertures 130 can be spaced apart from one anotherbetween about 0.1 mm to about 1.0 mm. The pair of inner apertures 128 ofthe first pair of fluid channels 122A can be positioned diametricallyopposed to or on opposite sides of the raised inner surface 132 from thepair of inner apertures 128 of the second pair of fluid channels 122B.

FIG. 1D also illustrates that each of the haptics 104 (e.g., any of thefirst haptic 104A or the second haptic 104B) can have an opticattachment end 136 and a closed free end 138. A haptic fluid port 140can be defined at the optic attachment end 136 of the haptic 104. Thehaptic fluid port 140 can serve as a chamber opening of the haptic fluidchamber 120. Fluid within the haptic fluid chamber 120 can flow out ofthe haptic fluid chamber 120 through the haptic fluid port 140 and intothe optic fluid chamber 110 via the pair of fluid channels 122 when thehaptic 104 is coupled to the optic portion 102. Similarly, fluid withinthe optic fluid chamber 110 can flow out of the optic fluid chamber 110through the pair of fluid channels 122 and into the haptic fluid chamber120 through the haptic fluid port 140.

As shown in FIGS. 1A and 1D, a haptic 104 can couple to the opticportion 102 at a reinforced portion 126. For example, the first haptic104A can couple or be attached to the optic portion 102 at the firstreinforced portion 126A and the second haptic 104B can couple or beattached to the optic portion 102 at the second reinforced portion 126B.

More specifically, the haptic attachment end 136 can couple to theprotruding outer surface 134 of the posterior element 108. Theprotruding outer surface 134 can also be referred to as a “landing” or“haptic attachment landing.” The protruding outer surface 134 can extendout radially from an outer peripheral surface 142 of the optic portion102. For example, the protruding outer surface 134 can extend outradially from an outer peripheral surface 142 of the posterior element108 of the optic portion 102. The protruding outer surface 134 canextend out radially from the outer peripheral surface 142 between about10 microns and 1.0 mm or between about 10 microns and 500 microns.

The haptic attachment end 136 can have a substantially flat surface toadhere or otherwise couple to a substantially flat surface of theprotruding outer surface 134. When the haptic attachment end 136 iscoupled to the protruding outer surface 134, the haptic fluid port 140can surround the outer apertures 130 of the fluid channels 122. Thehaptics 104 can be coupled or adhered to the optic portion 102 viabiocompatible adhesives 148. In some embodiments, the adhesives 148 canbe the same adhesives used to couple or adhere the anterior element 106to the posterior element 108. The adhesives 148 will be discussed inmore detail in the following sections.

Each of the haptics 104 can also comprise a radially outer portion 144configured to face and contact an inner surface of a patient's capsularbag when the adjustable AIOL 100 is implanted within the capsular bag.Each of the haptics 104 can also comprise a radially inner portion 146configured to face the outer peripheral surface 142 of the optic portion102. Engagement of the capsular bag with the radially outer portion 144of the haptics 104 will be discussed in more detail in the followingsections.

The optic portion 102 can have a base power or base spherical power. Thebase power of the optic portion 102 can be configured to change based onan internal fluid pressure within the fluid-filled optic fluid chamber110. The base power of the optic portion 102 can be configured toincrease or decrease as fluid enters or exits the fluid-filled opticfluid chamber 110.

The base power of the optic portion 102 can be configured to increase asfluid enters the fluid-filled optic fluid chamber 110 from the hapticfluid chamber(s) 120, as shown in FIG. 1B. The base power of the opticportion 102 can be configured to decrease as fluid exits or is drawn outof the fluid-filled optic fluid chamber 110 into the haptic fluidchamber(s) 120, as shown in FIG. 1C.

It should be noted that although FIG. 1B illustrates the fluid enteringthe optic fluid chamber 110 from the haptic fluid chambers 120 using thecurved broken-line arrows, fluid enters the optic fluid chamber 110 viathe fluid channels 122 (including through the inner apertures 128 andouter apertures 130) and haptic fluid ports 140. It should also be notedthat although FIG. 1C illustrates the fluid exiting the optic fluidchamber 110 into the haptic fluid chambers 120 using the curvedbroken-line arrows, fluid exits the optic fluid chamber 110 via thefluid channels 122 (including through the inner apertures 128 and outerapertures 130) and haptic fluid ports 140.

The optic portion 102 can be made in part of a deformable or flexiblematerial. In some embodiments, the optic portion 102 can be made in partof a deformable or flexible polymeric material. For example, theanterior element 106, the posterior element 108, or a combinationthereof can be made in part of a deformable or flexible polymericmaterial. The one or more haptics 104 (e.g., the first haptic 104A, thesecond haptic 104B, or a combination thereof) can be made in part of thesame deformable or flexible material as the optic portion 102. In otherembodiments, the one or more haptics 104 can be made in part ofdifferent materials from the optic portion 102.

In some embodiments, the optic portion 102 can comprise or be made inpart of a lens body material. The lens body material can be made in partof a cross-linked copolymer comprising a copolymer blend. The copolymerblend can comprise an alkyl acrylate or methacrylate, a fluoro-alkyl(meth)acrylate, and a phenyl-alkyl acrylate. It is contemplated by thisdisclosure and it should be understood by one of ordinary skill in theart that these types of acrylic cross-linked copolymers can be generallycopolymers of a plurality of acrylates, methacrylates, or a combinationthereof and the term “acrylate” as used herein can be understood to meanacrylates, methacrylates, or a combination thereof interchangeablyunless otherwise specified. The cross-linked copolymer used to make thelens body material can comprise an alkyl acrylate in the amount of about3% to 20% (wt %), a fluoro-alkyl acrylate in the amount of about 10% to35% (wt %), and a phenyl-alkyl acrylate in the amount of about 50% to80% (wt %). In some embodiments, the cross-linked copolymer can compriseor be made in part of an n-butyl acrylate as the alkyl acrylate,trifluoroethyl methacrylate as the fluoro-alkyl acrylate, andphenylethyl acrylate as the phenyl-alkyl acrylate. More specifically,the cross-linked copolymer used to make the lens body material cancomprise n-butyl acrylate in the amount of about 3% to 20% (wt %) (e.g.,between about 12% to 16%), trifluoroethyl methacrylate in the amount ofabout 10% to 35% (wt %) (e.g., between about 17% to 21%), andphenylethyl acrylate in the amount of about 50% to 80% (wt %) (e.g.,between about 64% to 67%).

The final composition of the cross-linked copolymer used to make thelens body material can also comprise a cross-linker or cross-linkingagent such as ethylene glycol dimethacrylate (EGDMA). For example, thefinal composition of the cross-linked copolymer used to make the lensbody material can also comprise a cross-linker or cross-linking agent(e.g., EGDMA) in the amount of about 1.0%. The final composition of thecross-linked copolymer used to make the lens body material can alsocomprise an initiator or initiating agent (e.g., Perkadox 16) and a UVabsorber.

The haptic(s) 104 can comprise or be made in part of a haptic material.The haptic material can comprise or be made in part of a cross-linkedcopolymer comprising a copolymer blend. The copolymer blend can comprisean alkyl acrylate, a fluoro-alkyl acrylate, and a phenyl-alkyl acrylate.For example, the cross-linked copolymer used to make the haptic materialcan comprise an alkyl acrylate in the amount of about 10% to 25% (wt %),a fluoro-alkyl acrylate in the amount of about 10% to 35% (wt %), and aphenyl-alkyl acrylate in the amount of about 50% to 80% (wt %). In someembodiments, the cross-linked copolymer used to make the haptic materialcan comprise n-butyl acrylate in the amount of about 10% to 25% (wt %)(e.g., between about 19% to about 23%), trifluoroethyl methacrylate inthe amount of about 10% to 35% (wt %) (e.g., between about 14% to about18%), and phenylethyl acrylate in the amount of about 50% to 80% (wt %)(e.g., between about 58% to about 62%). The final composition of thecross-linked copolymer used to make the haptic material can alsocomprise a cross-linker or cross-linking agent, such as EGDMA, in theamount of about 1.0%. The final composition of the cross-linkedcopolymer used to make the haptic material can also comprise a number ofphotoinitiators or photoinitiating agents (e.g., camphorquinone,1-phenyl-1,2-propanedione, and 2-ethylhexyl-4-(dimenthylamino)benzoate).

In some embodiments, the refractive index of the lens body material canbe between about 1.48 and about 1.53. In certain embodiments, therefractive index of the lens body material can be between about 1.50 andabout 1.53 (e.g., about 1.5178).

The optic portion 102 can be configured to deform, flex, or otherwisechange shape (see FIGS. 1B and 1C) in response to fluid entering orexiting the optic fluid chamber 110. The optic portion 102 can beconfigured to deform, flex, or otherwise change shape as a result of thematerial composition (e.g., the polymeric composition) of the opticportion 102 discussed heretofore. The haptic(s) 104 can also beconfigured to deform or otherwise change shape in response tointeractions or engagement with the capsular bag of a patient when theadjustable AIOL 100 is implanted within an eye of the patient. Thehaptic(s) 104 can be configured to deform or otherwise change shape as aresult of the material composition of the haptics 104.

In some embodiments, the anterior element 106 can be configured todeform, flex, or otherwise change shape (e.g., change its curvature) inresponse to fluid entering or exiting the optic fluid chamber 110. Inother embodiments, the posterior element 108 can be configured todeform, flex, or otherwise change shape (e.g., change its curvature) inresponse to fluid entering or exiting the optic fluid chamber 110. Infurther embodiments, both the anterior element 106 and the posteriorelement 108 can be configured to deform, flex, or otherwise change theirshapes in response to fluid entering or exiting the optic fluid chamber110.

In some embodiments, the fluid within the optic fluid chamber 110, thehaptic fluid chamber(s) 120, or a combination thereof can be an oil.More specifically, in certain embodiments, the fluid within the opticfluid chamber 110, the haptic fluid chamber(s) 120, or a combinationthereof can be a silicone oil or fluid. The fluid can flow between theoptic fluid chamber 110 and the haptic fluid chamber(s) 120 in responseto a deformation, flexing, or shape change undertaken by the haptic(s)104, component(s) of the optic portion 102 (e.g., the anterior element106, the posterior element 108, or a combination thereof), or acombination thereof.

The fluid within the optic fluid chamber 110, the haptic fluidchamber(s) 120, or a combination thereof can be a silicone oil or fluidcomprising or made in part of a diphenyl siloxane. In other embodiments,the silicone oil or fluid can comprise or be made in part of a ratio oftwo dimethyl siloxane units to one diphenyl siloxane unit. Morespecifically, in some embodiments, the silicone oil or fluid can be adiphenyltetramethyl cyclotrisiloxane. In additional embodiments, thesilicone oil or fluid can comprise or be made in part of a diphenylsiloxane and dimethyl siloxane copolymer.

The fluid (e.g., the silicone oil) can be index matched with the lensbody material used to make the optic portion 102. When the fluid isindex matched with the lens body material, the entire optic portion 102containing the fluid acts as a single lens. For example, the fluid canbe selected so that it has a refractive index of between about 1.48 and1.53 (or between about 1.50 and 1.53). In some embodiments, the fluid(e.g., the silicone oil) can have a polydispersity index of betweenabout 1.2 and 1.3. In other embodiments, the fluid (e.g., the siliconeoil) can have a polydispersity index of between about 1.3 and 1.5. Inother embodiments, the fluid (e.g., the silicone oil) can have apolydispersity index of between about 1.1 and 1.2. Other example fluidsare described in U.S. Patent Publication No. 2018/0153682, which isherein incorporated by reference in its entirety.

The base power of the optic portion 102 can be configured to change inresponse to the shape change undertaken by the shape-changing componentsof the optic portion 102 (e.g., the anterior element 106, the posteriorelement 108, or a combination thereof). The optic portion 102 can beconfigured to change shape in response to a physiologic muscle movement(e.g., ciliary muscle movement) undertaken by a patient when theadjustable AIOL 100 is implanted within a capsular bag of the eye of thepatient and the adjustable AIOL 100 deforms or changes shape in responseto ciliary muscle related capsular bag reshaping.

The adjustable AIOL 100 can be implanted or introduced into a patient'scapsular bag after a native lens has been removed from the capsular bag.The patient's capsular bag is connected to zonule fibers which areconnected to the patient's ciliary muscles. The capsular bag is elasticand ciliary muscle movements can reshape the capsular bag via the zonulefibers. For example, when the ciliary muscles relax, the zonules arestretched. This stretching pulls the capsular bag in the generallyradially outward direction due to radially outward forces. This pullingof the capsular bag causes the capsular bag to elongate, creating roomwithin the capsular bag. When the patient's native lens is present inthe capsular bag, the native lens normally becomes flatter (in theanterior-to-posterior direction), which reduces the power of the lens,allowing for distance vision. In this configuration, the patient'snative lens is said to be in a disaccommodated state or undergoingdisaccommodation.

When the ciliary muscles contract, however, as occurs when the eye isattempting to focus on near objects, the radially inner portion of themuscles move radially inward, causing the zonules to slacken. The slackin the zonules allows the elastic capsular bag to contract and exertradially inward forces on a lens within the capsular bag. When thepatient's native lens is present in the capsular bag, the native lensnormally becomes more curved (e.g., the anterior part of the lensbecomes more curved), which gives the lens more power, allowing the eyeto focus on near objects. In this configuration, the patient's nativelens is said to be in an accommodated state or undergoing accommodation.

Therefore, any AIOLs implanted within the capsular bag should alsopossess mechanisms which allow for the base power of the AIOL toincrease when the ciliary muscles contract and allow for the base powerof the AIOL to decrease when the ciliary muscles relax.

In the present case, when the adjustable AIOL 100 is implanted orotherwise introduced into a patient's native capsular bag, the radiallyouter portions 144 of the haptics 104 of the adjustable AIOL 100 candirectly engage with or be in physical contact with the portion of thecapsular bag that is connected to the zonules or zonule fibers.Therefore, the radially outer portions 144 of the haptics 104 can beconfigured to respond to capsular bag reshaping forces that are appliedradially when the zonules relax and stretch as a result of ciliarymuscle movements.

When the ciliary muscles contract, the peripheral region of the elasticcapsular bag reshapes and applies radially inward forces on the radiallyouter portions 144 of the haptics 104 (for example, the elastic capsularbag applies radially inward forces on the radially outer portion 144 ofthe first haptic 104A and on the radially outer portion 144 of thesecond haptic 104B). The radially outer portions 144 of the haptics 104then deform or otherwise changes shape and this deformation or shapechange causes the volume of the haptic fluid chambers 120 to decrease.When the volume of the haptic fluid chambers 120 decreases, the fluidwithin the haptic fluid chambers 120 is moved or pushed into the opticfluid chamber 110 within the optic portion 102. As discussed previously,fluid moves from the haptic fluid chamber 120 into the optic fluidchamber 110 through fluid channels 122 (e.g., a pair of fluid channels122) formed within the optic portion 102.

The optic portion 102 (any of the anterior element 106, the posteriorelement 108, or a combination thereof) can change shape (increase itscurvature) in response to the fluid entering the optic fluid chamber 110from the haptic fluid chambers 120. This increases the base power orbase spherical power of the adjustable AIOL 100 and allows a patientwith the adjustable AIOL 100 implanted within the eye of the patient tofocus on near objects. The adjustable AIOL 100 can also be considered tobe in an accommodated state or have undergone accommodation.

When the ciliary muscles relax, the peripheral region of the elasticcapsular bag is stretched radially outward and the capsular bagelongates and more room is created within the capsular bag. The radiallyouter portions 144 of the haptics 104 can be configured to respond tothis capsular bag reshaping by returning to its non-deformed ornon-stressed configuration. This causes the volume of the haptic fluidchambers 120 to increase or return to its non-deformed volume. Thisincrease in the volume of the haptic fluid chambers 120 causes the fluidwithin the optic fluid chamber 110 to be drawn out or otherwise flow outof the optic fluid chamber 110 and back into the haptic fluid chambers120. As discussed previously, fluid moves out of the optic fluid chamber110 into the haptic fluid chamber 120 through the same fluid channels122 (e.g., a pair of fluid channels 122) formed within the optic portion102.

As previously discussed, the optic portion 102 (any of the anteriorelement 106, the posterior element 108, or a combination thereof) canchange shape (decrease its curvature or become flatter) in response tothe fluid exiting the optic fluid chamber 110 and into the haptic fluidchambers 120. This decreases the base power or base spherical power ofthe adjustable AIOL 100 and allows a patient with the adjustable AIOL100 implanted within the eye of the patient to focus on distant objectsor provide for distance vision. The adjustable AIOL 100 can also beconsidered to be in a disaccommodated state or have undergonedisaccommodation.

As shown in FIGS. 1B and 1C, the radially inner portion 146 of thehaptics 104 can be designed to be thicker or bulkier (relative to theradially outer portion 144) to provide the haptics 104 with stiffness orresiliency in the anterior-to-posterior direction. This way, whencapsular bag forces are applied to the haptics 104 in theanterior-to-posterior direction, less deformation occurs and less fluidmovement occurs between the haptic fluid chambers 120 and the opticfluid chamber 110 than when forces are applied in the radial direction.Since less fluid movement occurs, less changes in the base power of theadjustable AIOL 100 occur when forces are applied to the adjustable AIOL100 in the anterior-to-posterior direction. Thus, the design andmaterial properties of the haptics 104 and the optic portion 102 canallow the adjustable AIOL 100 to maintain a high degree of sensitivityto radial forces applied to the haptics 104 by capsular bag reshapingcaused by ciliary muscle movements.

In some embodiments, the anterior element 106 can be configured suchthat the anterior optical surface 112 changes shape from a sphericalsurface configuration to an aspherical surface configuration in responseto fluid entering the optic fluid chamber 110. An aspherical surfaceconfiguration can correct for high order aberrations such as sphericalaberration. The fluid can enter the optic fluid chamber 110 from one ormore haptic fluid chambers 120 coupled to the optic portion 102 inresponse to ciliary muscle movement.

The anterior optical surface 112 can be stressed into the asphericalsurface configuration as a center or central portion of the anteriorelement 106 flexes or bulges out further than an outer periphery of theanterior element 106 which is held down by adhesives 148 or an adhesivelayer (see FIGS. 1B and 1C).

In other embodiments, the posterior element 108 can be configured suchthat the posterior optical surface 116 changes shape from a sphericalsurface configuration to an aspherical surface configuration in responseto fluid entering the optic fluid chamber 110.

The posterior optical surface 116 can be stressed into the asphericalsurface configuration as a center or central portion of the posteriorelement 108 flexes or bulges out further than an outer periphery of theanterior element 106 which is held down by adhesives 148 or the adhesivelayer.

The anterior element 106 can be attached or otherwise adhered to theposterior element 108 via adhesives 148 or an adhesive layer. Theadhesive layer can be substantially annular-shaped. The adhesives 148 oradhesive layer can be positioned at a peripheral edge 150 (see FIG. 1D)of the optic portion 102 in between the anterior element 106 and theposterior element 108. For example, the adhesives 148 can be positionedon top of the raised inner surface 132 of the posterior element 108.

The adhesives 148 or adhesive layer can comprise or be made in part of abiocompatible adhesive. The adhesives 148 or adhesive layer can compriseor be made in part of a biocompatible polymeric adhesive.

The adhesives 148 or adhesive layer can comprise or be made in part of across-linkable polymer precursor formulation. The cross-linkable polymerprecursor formulation can comprise or be made in part of a copolymerblend, a hydroxyl-functional acrylic monomer, and a photoinitiator.

The copolymer blend can comprise an alkyl acrylate (e.g., n-butylacrylate in the amount of about 41% to about 45% (wt %)), a fluoro-alkylacrylate (e.g., trifluoroethyl methacrylate in the amount of about 20%to about 24% (wt %)), and a phenyl-alkyl acrylate (phenylethyl acrylatein the amount of about 28% to about 32% (wt %)). The hydroxyl-functionalacrylic monomer can be 2-hydroxyethyl acrylate (HEA).The photoinitiatorcan be used to facilitate curing of the adhesive. For example, thephotoinitiator can be Darocur 4265 (a 50/50 blend ofdiphenyl(2,4,6-trimethylbenzoyl)phosphine oxide and2-hydroxy2-methylpropiophenone).

The first step in making the adhesive is preparation of ahydroxyl-functional polymer precursor by photopolymerizing thecross-linkable polymer precursor formulation, thereby yielding a curedcomposition. The second step is chemical conversion of the precursorpolymer pendant hydroxyl moieties, or hydroxyl pendant groups, intopendant methacrylate functional groups by reacting with a methacrylicanhydride or methacryloyl chloride, thus forming amethacrylate-functional or methacrylic-functional cross-linkable polymercomprising the alkyl acrylate or methacrylate (e.g., n-butyl acrylate),the fluoro-alkyl (meth)acrylate (e.g., trifluoroethyl methacrylate), thephenyl-alkyl acrylate (phenylethyl acrylate), and2-(2-methyl-acryloyloxy)ethyl acrylate.

The methacrylic-functional cross-linkable polymer can be blended with areactive acrylic monomer diluent such as 1-adamantyl methacrylate (ADMA)and the same photoinitiator (e.g., Darocur 4265). For example, the finalcomposition of the adhesives 148 can comprise the cross-linkable polymerprecursor formulation in the amount of about 50% to about 85% (wt %)(e.g., about 61% to about 65%), the reactive acrylic monomer diluent inthe amount of about 10% to about 40% (wt %) (32% to about 36%), and thephotoinitiator (e.g., Darocur 4265) in the amount of about 2% to about3% (wt %).

The adhesives 148 or adhesive layer can bond, adhere, or otherwise jointhe anterior element 106 to the posterior element 108. As will bediscussed in more detail in the following sections, the thickness of theadhesive layer can be adjusted post-implantation to adjust a base powerof the adjustable AIOL 100.

In some embodiments, the same adhesives 148 used to bond the anteriorelement 106 to the posterior element 108 can also be used to bond oraffix the peripheral portion 103 (e.g., the one or more haptics 104) tothe optic portion 102.

In certain embodiments, the anterior optical surface 112 of the anteriorelement 106 can be manufactured to have an aspherical optical surfaceprior to the adjustable AIOL 100 being implanted within the eye of thepatient. In these embodiments, the anterior optical surface 112 can beaspheric regardless of any fluid pressure changes within the optic fluidchamber 110. In these embodiments, the anterior optical surface 112 canalso maintain its asphericity across all base power changes.

In other embodiments, the posterior optical surface 116 of the posteriorelement 108 can be manufactured to have an aspherical optical surfaceprior to the adjustable AIOL 100 being implanted within the eye of thepatient. In these embodiments, the posterior optical surface 116 can beaspheric regardless of any fluid pressure changes within the optic fluidchamber 110. In these embodiments, the posterior optical surface 116 canmaintain its asphericity across all base power changes.

In some embodiments, the anterior element 106 can have a thickness atits center or central portion that is greater than a thickness at itsperiphery. In certain embodiments, the posterior element 108 can alsohave a thickness at its center or central portion that is greater than athickness at its periphery.

As shown in FIGS. 1B-1D, the optic portion 102 can have an optical axis152. The optical axis 152 can extend in an anterior-to-posteriordirection through a center or center point of the optic portion 102. Theoptical axis 152 can extend through the centers or center points of boththe anterior element 106 and the posterior element 106.

The thickness of the anterior element 106 can be greater at the opticalaxis 152 or near the optical axis 152 than at the periphery of theanterior element 106. In some embodiments, the thickness of the anteriorelement 106 can increase gradually from the periphery of the anteriorelement 106 toward the optical axis 152.

In certain embodiments, the thickness of the anterior element 106 at theoptical axis 152 or near the optical axis 152 can be between about 0.45mm and about 0.55 mm. In these and other embodiments, the thickness ofthe anterior element 106 near the periphery can be between about 0.20 mmand about 0.40 mm. This difference in thickness can contribute to theanterior optical surface 112 changing shape from a spherical surfaceconfiguration to an aspherical surface configuration as fluid enters thefluid-filled optic fluid chamber 110 from the haptic fluid chamber(s)120.

Moreover, the anterior inner surface 114 of the anterior element 106 canhave less curvature or be flatter than the anterior optical surface 112.This difference in surface curvature between the anterior inner surface114 and the anterior optical surface 112 can also contribute to theanterior optical surface 112 changing shape from the spherical surfaceconfiguration to the aspherical surface configuration as fluid entersthe fluid-filled optic fluid chamber 110 from the haptic fluidchamber(s) 120.

In other embodiments, the thickness of the posterior element 108 can begreater at the optical axis 152 or near the optical axis 152 thanportions of the posterior element 108 radially outward from the opticalaxis 152 but prior to reaching the raised inner surface 132. Thethickness of the posterior element 108 can gradually decrease from theoptical axis 152 to portions radially outward from the optical axis 152(but prior to reaching the raised inner surface 132). The thickness ofthe posterior element 108 can increase again from the beginning of theraised inner surface 132 to the peripheral edge 150.

In certain embodiments, the thickness of the posterior element 108 atthe optical axis 152 or near the optical axis 152 can be between about0.45 mm and about 0.55 mm. In these and other embodiments, the thicknessof the posterior element 108 radially outward from the optical axis 152(but prior to reaching the raised inner surface 132) can be betweenabout 0.20 mm and about 0.40 mm. The thickness of the posterior element108 near the peripheral edge 150 can be between about 1.00 mm and 1.15mm. This difference in thickness can contribute to the posterior opticalsurface 116 changing shape from the spherical surface configuration tothe aspherical surface configuration as fluid enters the fluid-filledoptic fluid chamber 110 from the haptic fluid chamber(s) 120.

Moreover, the posterior inner surface 118 of the posterior element 108can have less curvature or be flatter than the posterior optical surface116. This difference in surface curvature between the posterior innersurface 118 and the posterior optical surface 116 can also contribute tothe posterior optical surface 116 changing shape from the sphericalsurface configuration to the aspherical surface configuration as fluidenters the fluid-filled optic fluid chamber 110 from the haptic fluidchamber(s) 120.

FIG. 2A is a graphic representation of a composite material 200comprising a composite base material 202, an energy absorbingconstituent 204, and a plurality of expandable components 206. In someembodiments, the optic portion 102 of the adjustable AIOL 100 can bemade in part of the composite material 200. In other embodiments, theperipheral portion 103 of the adjustable AIOL 100 can be made in part ofthe composite material 200. In further embodiments, both the opticportion 102 and the peripheral portion 103 of the adjustable AIOL 100can be made in part of the composite material 200.

The composite base material 202 can comprise a methacrylate-functionalor methacrylic-functional cross-linkable polymer and reactive acrylicmonomer diluents including lauryl methacrylate (n-dodecyl methacrylateor SR313) and ADMA. By controlling the amount of lauryl methacrylate(SR313) to ADMA, the overall corresponding hardness (i.e., more ADMA) orsoftness (i.e., more SR313) of the cured composite material 200 can becontrolled. The methacrylate-functional or methacrylic-functionalcross-linkable polymer can be made using the cross-linkable polymerprecursor formulation. The cross-linkable polymer precursor formulationcan be the same cross-linkable polymer precursor formulation used aspart of the formulation for the adhesives 148.

As previously discussed, the optic portion 102 can comprise or be madein part of the lens body material. Also, as previously discussed, theperipheral portion 103 (e.g., the one or more haptics 104) can compriseor be made in part of the haptic material. The cross-linkable polymerprecursor formulation can comprise the same copolymer blend used to makethe lens body material, the haptic material, or the adhesives.

The copolymer blend can comprise an alkyl acrylate or methacrylate(e.g., n-butyl acrylate), a fluoro-alkyl (meth)acrylate (e.g.,trifluoroethyl methacrylate), and a phenyl-alkyl acrylate (e.g.,phenylethyl acrylate). For example, the copolymer blend can comprisen-butyl acrylate in the amount of about 41% to about 45% (wt %),trifluoroethyl methacrylate in the amount of about 20% to about 24% (wt%), and phenylethyl acrylate in the amount of about 28% to about 32% (wt%). As previously discussed, the cross-linkable polymer precursorformulation can comprise or be made in part of the copolymer blend, ahydroxyl-functional acrylic monomer (e.g., HEA), and a photoinitiator(e.g., Darocur 4265 or a 50/50 blend ofdiphenyl(2,4,6-trimethylbenzoyl)-phosphine oxide and2-hydroxy2-methylpropiophenone).

The composite base material 202 can comprise the methacrylate-functionalor methacrylic-functional cross-linkable polymer (as discussed above) inthe amount of about 50% to about 65% (e.g., about 55% to about 60%) (wt%), the reactive acrylic monomer diluent lauryl methacrylate (SR313) inthe amount of about 32% to about 38% (e.g., about 32.70%) (wt %), thereactive acrylic monomer diluent adamantly methacrylate (ADMA) in theamount of about 5% to about 9% (e.g., about 7.30%) (wt %).

The composite material 200 can be made in several operations. The firstoperation can comprise preparing an uncolored composite base material202. The second operation can comprise mixing the composite basematerial 202 with an energy absorbing constituent 204, expandablecomponents 206, and initiators such as one or more photoinitiators,thermal initiators, or a combination thereof. The third operation cancomprise placing the uncured composite material 200 into a desiredlocation within the optic portion 102, the haptic(s) 104, or acombination thereof, and curing the composite material 200 in place toform the adhered composite material 200.

For example, the uncolored composite base material 202 can be mixed withan energy absorbing constituent 204 such as a dye (e.g., Disperse Red 1dye) or pigment (graphitized carbon black). The energy absorbingconstituent 204 will be discussed in more detail below.

In some embodiments, the expandable components 206 can make up about5.0% to about 15.0% by weight of a final formulation of the compositematerial 200. More specifically, the expandable components 206 can makeup about 8.0% to about 12.0% (e.g., about 10.0%) by weight of a finalformulation (see Table 1) of the composite material 200. In these andother embodiments, the energy absorbing constituent 204 can make upabout 0.044% to about 0.44% (or about 0.55%) by weight of the finalformulation of the composite material 200.

The photoinitiator can be Omnirad 2022(bis(2,4,6-trimethylbenzoyl)phenyl-phosphineoxide/2-hydroxy-2-methyl-1-phenyl-propan-1-one).The photoinitiator can make up about 1.30% by weight of a finalformulation of the composite material 200 (see, e.g., Table 1). Inaddition, the composite material 200 can also comprise a thermalinitiator. The thermal initiator can make up about 1.00% by weight of afinal formulation of the composite material 200 (see, e.g., Table 1). Insome embodiments, the thermal initiator can be a dialkyl peroxide suchas Luperox® peroxide. In other embodiments, the thermal initiator can bePerkadox.

Table 1 below provides an example formulation for the composite material200:

TABLE 1 FORMULATION OF COMPOSITE MATERIAL (WT %) Cross-linkable polymer1.47% 2-hydroxyethyl acrylate (HEA) (in two steps from 1.96% Darocur4265 (photoinitiator) precursor formulation, 43.50% n-butylacrylate(nBA) as described above) 30.21% 2-phenylethylacrylate (PEA) 22.87%2,2,2-trifluoroethylmethacrylate (TFEMA) Composite base material 60.00%cross-linkable polymer 32.70% lauryl methacrylate (SR313) 7.30%1-adamantyl methacrylate (ADMA) Composite base material 99.50% compositebase material with red energy 0.50% Disperse Red 1 dye absorbingcolorant Composite base material 99.95% composite base material withblack energy 0.05% graphitized mesoporous carbon black absorbingcolorant Final formulation of 87.70% composite base material withcomposite material red or black energy absorbing colorant 10.00%expandable microspheres 1.00% Luperox peroxide (thermal initiator) 1.30%Omnirad 2022

FIG. 2B illustrates that the expandable components 206 can be expandablemicrospheres comprising an expandable thermoplastic shell 208 and ablowing agent 210 contained within the expandable thermoplastic shell208. The microspheres can be configured to expand such that a diameter212 of at least one of the microspheres can increase about 2× theoriginal diameter. In other embodiments, the microspheres can beconfigured to expand such that the diameter 212 of at least one of themicrospheres can increase about 4× or four times the original diameter.In further embodiments, the microspheres can be configured to expandsuch that the diameter 212 of at least one of the microspheres canincrease between about 2× and about 4× (or about 3.5×) the originaldiameter. For example, the microspheres can have a diameter 212 of about12 μm at the outset. In response to an external energy applied ordirected at the composite material 200 or in response to energytransferred or transmitted to the microspheres, the diameter 212 of themicrospheres can increase to about 40 μm.

The volume of at least one of the microspheres can be configured toexpand between about ten times (10×) to about 50 times (50×) in responseto the external energy applied or directed at the composite material 200or in response to energy transferred or transmitted to the microspheres.

In some embodiments, the blowing agent 210 can be an expandable fluid,such as an expandable gas. More specifically, the blowing agent 210 canbe a branched-chain hydrocarbon. For example, the blowing agent 210 canbe isopentane. In other embodiments, the blowing agent 210 can be orcomprise cyclopentane, pentane, or a mixture of cyclopentane, pentane,and isopentane.

FIG. 2B illustrates that each of the expandable components 206 cancomprise a thermoplastic shell 208. FIG. 2B also illustrates that athickness of the thermoplastic shell 208 can change as the expandablecomponent 206 increases in size. More specifically, the thickness of thethermoplastic shell 208 can decrease as the expandable component 206increases in size. For example, when the expandable components 206 areexpandable microspheres, the thickness of the thermoplastic shell 208(i.e., its thickness in a radial direction) can decrease as the diameter212 of the expandable microsphere increases.

For example, as previously discussed, at least one of the expandablemicrospheres can have a diameter 212 of about 12 μm at the outset. Inthis embodiment, the thermoplastic shell 208 of the expandablemicrosphere can have a shell thickness of about 2.0 μm. In response toan external energy applied or directed at the composite material 200 orin response to energy transferred or transmitted to the microsphere, thediameter 212 of the microsphere can increase to about 40 μm (and thevolume expand between about 10× and 50×) and the shell thickness of themicrosphere can decrease to about 0.1 μm.

Although FIGS. 2A and 2B illustrate the expandable components 206 asspheres or microspheres, it is contemplated by this disclosure that theexpandable components 206 can be substantially shaped as ovoids,ellipsoids, cuboids or other polyhedrons, or a combination thereof.

In some embodiments, the thermoplastic shell 208 can be made in part ofnitriles or acrylonitrile copolymers. For example, the thermoplasticshell 208 can be made in part of acrylonitrile, styrene, butadiene,methyl acrylate, or a combination thereof.

As previously discussed, the expandable components 206 can make upbetween about 8.0% to about 12% by weight of a final formulation of thecomposite material 200. The expandable components 206 can make up about10% by weight of a final formulation of the composite material 200.

The expandable components 206 can be dispersed or otherwise distributedwithin the composite base material 202 making up the bulk of thecomposite material 200. The composite base material 202 can serve as amatrix for holding or carrying the expandable components 206. Thecomposite material 200 can expand in response to an expansion of theexpandable components 206 (e.g., the thermoplastic microspheres). Forexample, a volume of the composite material 200 can increase in responseto the expansion of the expandable components 206.

The composite material 200 also comprises an energy absorbingconstituent 204. In some embodiments, the energy absorbing constituent204 can be an energy absorbing colorant.

In certain embodiments, the energy absorbing colorant can be an energyabsorbing dye. For example, the energy absorbing dye can be an azo dye.In some embodiments, the azo dye can be a red azo dye such as DisperseRed 1 dye. In other embodiments, the azo dye can be an orange azo dyesuch as Disperse Orange dye (e.g., Disperse Orange 1), a yellow azo dyesuch as Disperse Yellow dye (e.g., Disperse Yellow 1), a blue azo dyesuch as Disperse Blue dye (e.g., Disperse Blue 1), or a combinationthereof.

In additional embodiments, the energy absorbing colorant can be orcomprise a pigment. For example, the energy absorbing colorant can be orcomprise graphitized carbon black as the pigment.

Similar to the expandable components 206, the energy absorbingconstituent 204 can be dispersed or otherwise distributed within thecomposite base material 202 making up the bulk of the composite material200. The composite base material 202 can serve as a matrix for holdingor carrying the expandable components 206 and the energy absorbingconstituent 204.

As previously discussed, the energy absorbing constituent 204 can makeup between about 0.025% to about 1.0% (or, more specifically, about0.045% to about 0.45%) by weight of a final formulation of the compositematerial 200. For example, when the energy absorbing constituent 204 isa dye (e.g., an azo dye such as Disperse Red 1), the energy absorbingconstituent 204 can make up about between about 0.45% to about 1.0% byweight of a final formulation of the composite material 200. When theenergy absorbing constituent 204 is graphitized carbon black or othertypes of pigments, the energy absorbing constituent 204 can make upabout 0.025% to about 0.045% by weight of a final formulation of thecomposite material 200.

The energy absorbing constituent 204 (e.g., azo dye, graphitized carbonblack, or a combination thereof) can absorb or capture an externalenergy applied or directed at the composite material 200. The energyabsorbing constituent 204 can absorb or capture the external energy andthen transform or transfer the energy into thermal energy or heat to theexpandable components 206.

The thermoplastic shell 208 can soften and begin to flow as thermalenergy is transferred or transmitted to the expandable components 206.The thermoplastic shell 208 of the expandable components 206 can thenbegin to thin or reduce in thickness in response to the thermal energytransferred or transmitted to the expandable components 206. As thethermoplastic shell 208 begins to soften and reduce in thickness, theblowing agent 210 within the expandable components 206 can expand. Theblowing agent 210 can also expand in response to the thermal energy orheat transferred or transmitted to the expandable components 206.Expansion of the blowing agents 210 can cause the expandable components206 (e.g., the thermoplastic microspheres) to expand or increase involume. This ultimately causes the composite material 200 to expand orincrease in volume.

The composite material 200 can expand or increase in size in anisotropic manner such that the composite material 200 expands in alldirections. Such isotropic expansion can be harnessed to produceexpansion or material displacement in specific directions by placing orpositioning the composite material 200 at specific locations along thehaptic(s) 104 or optic portion 102 of the adjustable AIOL 100.

As will be discussed in more detail in the following sections, in someembodiments, the external energy can be light energy and the energyabsorbing constituent 204 can absorb or capture the light energydirected at the composite material 200 and transform or transfer thelight energy into thermal energy or heat to the expandable components206. The blowing agent 210 within the expandable components 206 canexpand or become energized in response to the thermal energy or heat.The expandable components 206 and, ultimately, the composite material200 can expand or increase in volume in response to this light energydirected at the composite material 200.

The shape change (e.g., increase in volume) undertaken by the expandablecomponents 206 can be a persistent change or a substantially permanentchange. A persistent change or substantially permanent change can meanthat the expandable components 206 do not substantially revert back toits original shape or size after the shape change (e.g., after anincrease in volume) has occurred. As a result, any change in the size orvolume of the composite material 200 caused by a change in the size orvolume of the expandable components 206 is also persistent orsubstantially permanent. As will be discussed in more detail in thefollowing sections, this means that any structural changes made to theadjustable AIOL 100 as a result of external energy or stimulus appliedor otherwise directed at the composite material 200 embedded orintegrated within the adjustable AIOL 100 can persist or remainsubstantially permanent.

The thermoplastic shells 208 of the expandable components 206 canharden, once again, when the external energy is no longer directed orapplied to the composite material 200. The thermoplastic shells 208 ofthe expandable components 206 can harden, once again, when thetemperature within a vicinity of the expandable components 206 fallsbelow a certain threshold. For example, the thermoplastic shells 208 ofthe expandable microspheres can harden when light energy is no longerdirected at the composite material 200. After the thermoplastic shells208 harden, the expandable components 206 are locked into their new sizeand expanded configuration.

When the energy absorbing constituent 204 is an energy absorbingcolorant, such as a dye or graphitized carbon, the color of at leastpart of the composite material 200 can take on the color of the energyabsorbing colorant. For example, when the energy absorbing constituent204 is an azo dye such as Disperse Red 1 having a red color, at least aportion of the composite material 200 comprising the energy absorbingconstituent 204 can be colored red. Moreover, when the energy absorbingconstituent 204 is graphitized carbon having a black color, at least aportion of the composite material 200 comprising the energy absorbingconstituent 204 can be colored black. Although two colors (e.g., red andblack) are mentioned in this disclosure, it is contemplated by thisdisclosure and it should be understood by one of ordinary skill in theart that energy absorbing colorant of other types of colors can also beused such as energy absorbing yellow, orange, or blue dyes or materials.

The color of the energy absorbing colorant can be visually perceptibleto a clinician or another medical professional when the adjustable AIOL100 is made in part of the composite material 100 comprising the energyabsorbing colorant. The color of the energy absorbing colorant can bevisually perceptible to a clinician or another medical professional whenthe adjustable AIOL 100 is implanted within an eye of a patient. Forexample, the composite material 200 can comprise Disperse Red 1 servingas the energy absorbing colorant. In this example, at least part of theadjustable AIOL 100 can appear red to the clinician or another medicalprofessional when the adjustable AIOL 100 is implanted within the eye ofa patient.

The color of the energy absorbing colorant can allow the clinician oranother medical professional detect or determine the location orposition of the composite material 200 within the adjustable AIOL 100.The color of the energy absorbing colorant can also allow the clinicianor another medical professional to determine where to direct theexternal energy or stimulus to adjust the adjustable AIOL 100.

As will be discussed in more detail in the following sections, at leastpart of the adjustable AIOL 100 can be made of a composite material 200comprising an energy absorbing constituent 204 of a first color (e.g.,red) and another part of the adjustable AIOL 100 can be made ofadditional composite material 200 comprising an energy absorbingconstituent 204 of a second color (e.g., black). By designing theadjustable AIOL 100 in this manner, a clinician or another medicalprofessional can direct external energy or stimulus at different partsof the adjustable AIOL 100 using the different colors of the compositematerials 200 as guides or markers for distinguishing between differentlocations of such target sites. Moreover, the different coloredcomposite materials 200 can also serve as indicators or visual cues asto where to direct the external energy or stimulus to cause certainchanges in one or more optical parameters (e.g., the base power, thecylindricity, or a combination thereof) of the adjustable AIOL 100.

One technical problem faced by the applicants is how to integrate anadjustable composite material into an optic portion and a peripheralportion (e.g., the haptics) of an AIOL such that the adjustablecomposite material would adhere to the lens material used to make therest of the AIOL and remain substantially fixed at certain locationswithin the optic portion or peripheral portion. One solution discoveredby the applicants and disclosed herein is the unique composition of thecomposite material which incorporates the same copolymer blend used tomake the lens body material and the haptic material. Moreover, thecomposite material is made in part in the cross-linkable polymerprecursor formulation used in the adhesive for adhering parts of theAIOL to one another. By designing the AIOL in this manner, the compositematerial is compatible with the rest of the material used to constructthe optic portion and the peripheral portion and remains substantiallyfixed at its location without migrating or shifting.

Another technical problem faced by the applicants is how to ensure thatany adjustments made to the AIOL persist long after the adjustmentprocedure. One solution discovered by the applicants and disclosedherein is to induce an expansion of a composite material made in part ofexpandable microspheres comprising a blowing agent contained withinthermoplastic shells. The thermoplastic shells can soften (and thethickness of the thermoplastic shells can decrease) in response to anexternal energy directed or applied at the composite material (which canresult in heat or thermal energy being transferred or transmitted to theexpandable microspheres). The blowing agent within the thermoplasticshells can expand as the thermoplastic shells soften. Expansion of theblowing agent can expand the microspheres, which can, in turn, expandthe composite base material serving as the bulk of the compositematerial. The expandable microspheres can retain their new enlarged orexpanded configuration even after the external energy is no longerapplied to the composite material.

Moreover, the composite material also comprises an energy absorbingconstituent such as an energy absorbing dye or colorant. The energyabsorbing constituent can capture or absorb a relatively harmlessexternal energy or stimulus directed at the composite material andtransform or transfer the external energy into thermal energy which canthen cause the thermoplastic microspheres to expand. By designing theadjustable AIOL 100 in this manner, one or more bursts or pulses ofrelatively harmless energy or stimulus (e.g., light energy) can be usedto induce a persistent change in the shape or size of at least part ofthe adjustable AIOL 100. This persistent change in the shape or size ofthe adjustable AIOL 100 can have a continuing effect on an opticalparameter of the lens including, for example, its base power.

FIGS. 3A and 3B illustrate sectional views of an embodiment of theadjustable AIOL 100 comprising an expandable spacer 300 made at least inpart of the composite material 200. The expandable spacer 300 can bepositioned or otherwise disposed in a radially inner portion 146 of theperipheral portion 103 (e.g., a haptic 104) of the adjustable AIOL 100.

As shown in FIGS. 3A and 3B, the radially inner portion 146 of thehaptic 104 can be radially thicker or bulkier than the radially outerportion 144. FIGS. 3A and 3B also illustrate the adjustable AIOL 100 asbeing implanted within an eye of a patient and, more specifically, asbeing positioned within a capsular bag 304 of the patient (shown inFIGS. 3A and 3B using broken lines). The radially outer portion 144 ofthe haptic 104 can come into physical contact or push against an innersurface of the capsular bag 304 when the adjustable AIOL 100 ispositioned within the capsular bag 304.

As shown in FIGS. 3A and 3B, the expandable spacer 300 can be positionedpartially within the radially inner portion 146 of the haptic 104. Insome embodiments, at least part of the expandable spacer 300 can jut outor extend out radially inward or laterally toward the outer peripheralsurface 142 of the optic portion 102. In these and other embodiments, atleast part of the expandable spacer 300 can be positioned in between thehaptic 104 and the optic portion 102. More specifically, the expandablespacer 300 can be positioned in between (e.g., radially in between) theoptic portion 102 and the haptic fluid chamber 120.

In some embodiments, the expandable spacer 300 can be adhered to theradially inner portion 146 of the haptic 104 by being cured into place.For example, the expandable spacer 300 can be adhered to a furrow,indentation, or groove formed along the radially inner portion 146.

In other embodiments, the expandable spacer 300 can be positionedentirely within the radially inner portion 146 of the haptic 104. Insome embodiments, a cavity, conduit, or other void space can be formedwithin the radially inner portion 146 and the expandable spacer 300 canbe introduced into the cavity, conduit, or void space and cured intoplace.

In further embodiments, the expandable spacer 300 can refer to part ofthe peripheral portion 103 (e.g., the haptic 104) made of the compositematerial 200. For example, the expandable spacer 300 can refer to partof the radially inner portion 146 of the haptic 104 made of thecomposite material 200.

Although FIGS. 3A and 3B illustrate the expandable spacer 300 as havinga rectangular cross-sectional profile, it is contemplated by thisdisclosure and it should be understood by one of ordinary skill in theart that the cross-sectional profile of the expandable spacer 300 can besubstantially shaped as an oval, a circle, triangular or anotherpolygon.

FIGS. 3A and 3B also illustrate that an external energy 302 can bedirected or otherwise applied to the expandable spacer 300 to induce ashape change in the expandable spacer 300 (e.g., enlarge the expandablespacer 300) to affect an optical parameter of the adjustable AIOL 100.

In some embodiments, the external energy 302 can be light energy. Morespecifically, the external energy 302 can be laser light. In certainembodiments, the laser light can have a wavelength between about 488 nmto about 650 nm. The external energy 302 can be one or more bursts orpulses of laser light.

In some embodiments, the laser light can be green laser light. The greenlaser light can have a wavelength of between about 520 nm to about 570nm. In one example, embodiment, the external energy 302 can be greenlaser light having a wavelength of about 532 nm.

For example, the laser light can be laser light emitted by an ophthalmiclaser. For example, the laser light can be laser light emitted by aretinal coagulation laser.

When the external energy 302 is light energy, the energy absorbingconstituents 204 can absorb or otherwise capture the light energy andconvert the light energy into thermal energy to cause the expandablecomponents 206 within the composite material 200 to expand.

As shown in FIG. 3B, the external energy 302 can cause the expandablespacer 300 to expand. Expansion of the expandable spacer 300 can causethe spacer 300 to push against the outer peripheral surface 142 of theoptic portion 102. For example, the enlarged expandable spacer 300 canpush against the posterior element 108 of the optic portion 102. Sincethe periphery of the posterior element 108 is relatively thick or bulkyin between the outer peripheral surface 142 and the raised inner surface132, the enlarged expandable spacer 300 primarily exerts a radiallyoutward force or laterally outward force on the haptic 104.

FIG. 3B illustrates that the haptic 104 can be biased or pushed againstthe sides of the capsular bag 304. More specifically, the enlargedexpandable spacer 300 can bias or push the radially inner portion 146 ofthe haptic 104 radially outward. For example, FIG. 3B illustrates theradially outward displacement of the radially inner portion 146 of thehaptic 104 using solid lines to indicate the position of the radiallyinner portion 146 after the expansion and broken-lines to indicate theposition of the radially inner portion 146 prior to the expansion. Giventhe limited amount of space within the capsular bag 304, this radiallyoutward displacement of the radially inner portion 146 of the haptic 104can cause the chamber walls of the haptic fluid chamber 120 to compressor squeeze together, thereby decreasing a volume of the haptic fluidchamber 120.

As previously discussed, both the haptic fluid chamber(s) 120 and theoptic fluid chamber 110 can be filled with a fluid (e.g., silicone oil).Decreasing the volume of the haptic fluid chamber 120 can cause at leastsome of the fluid within the haptic fluid chamber(s) 120 to flow fromthe haptic fluid chamber(s) 120 into the optic fluid chamber 120.Moreover, as previously discussed, the haptic fluid chamber(s) 120 canbe in fluid communication with the optic fluid chamber 120 through aplurality of fluid channels 122 (including the first pair of fluidchannels 122A, the second pair of fluid channels 122B, or a combinationthereof, see FIG. 1A). Although fluid flow between the haptic fluidchamber 120 and the optic fluid chamber 120 is shown in FIG. 3B usingthe curved arrow depicted using broken-lines, it should be understood byone of ordinary skill in the art that fluid flows from the haptic fluidchamber(s) 120 to the optic fluid chamber 120 via the plurality of fluidchannels 122.

As previously discussed, the base power of the optic portion 102 can beconfigured to change based on an internal fluid pressure within thefluid-filled optic fluid chamber 110. The base power of the opticportion 102 can be configured to increase as fluid enters the opticfluid chamber 110 from the haptic fluid chamber(s) 120.

The optic portion 102 can also be configured to change shape in responseto fluid entering the optic fluid chamber 110. In certain embodiments,the anterior element 106 of the optic portion 102 can be configured tochange shape (e.g., increase its curvature) in response to the fluidentering the optic fluid chamber 110. In other embodiments, theposterior element 108 of the optic portion 102 can be configured tochange shape (e.g., increase its curvature) in response to the fluidentering the optic fluid chamber 110. In further embodiments, both theanterior element 106 and the posterior element 108 can be configured tochange shape in response to the fluid entering the optic fluid chamber110. The base power of the optic portion 102 can be configured toincrease in response to the shape change(s) undertaken by the anteriorelement 106, the posterior element 108, or a combination thereof.

As depicted in FIGS. 3A and 3B, when the expandable spacer 300 ispositioned in between the optic portion 102 and the haptic fluidchamber(s) 120, applying an external energy 302 to the expandable spacer300 can cause an interaction between the haptic(s) 104 and a capsularenvironment (e.g., the sides of the capsular bag 304) surrounding thehaptic(s) 104. This interaction between the haptic(s) 104 and thecapsular environment can result in an increase of the base power of theadjustable AIOL 100.

For example, adjusting a base power of the adjustable AIOL 100 cancomprise directing or applying an external energy 302 (e.g., lightenergy between about 520 nm to about 570 nm) at the adjustable AIOL 100implanted within an eye of the patient. More specifically, the externalenergy 302 can be applied or directed at an expandable spacer 300 madein part of the composite material 200. The expandable spacer 300 canexpand in response to the application of the external energy 302.Expansion of the spacer 300 can result in the haptic(s) 104 being pushedor biased radially or laterally outward against the sides of thecapsular bag 304. This can result in the walls of the haptic fluidchamber 120 being compressed or squeezed together such that a volume ofthe haptic fluid chamber 120 is reduced. Fluid within the haptic fluidchamber(s) 120 can then flow into the optic fluid chamber 110 inresponse to this reduction in the volume of the haptic fluid chamber(s)120. The base power of the optic portion 102 can increase in response tothis fluid flow into the optic fluid chamber 110.

In some embodiments, bursts or pulses of external energy 302 (e.g.,light energy) directed at the expandable spacer 300 can result in anincrease in the base power of the adjustable AIOL 100 by between about+0.10 D and about +0.20 D (e.g., about +0.125 D). For example, pulses ofgreen laser light directed at the expandable spacer 300 can result in anincrease in the base power of the adjustable AIOL 100 by between about+0.10 D and about +0.20 D (e.g., about +0.125 D). In some embodiments,the base power of the adjustable AIOL 100 can increase between about+1.0 D to about +5.0 D (e.g., about +2.0 D) in total in response tobursts or pulses of the external energy 302 directed at the expandablespacer 300.

FIGS. 4A and 4B are top and sectional views, respectively, of anembodiment of the adjustable AIOL 100 comprising the expandable spacer300 extending radially inward toward the optic portion 102 and occupyinga gap space 400 in between the haptic(s) 104 and the optic portion 102.

The adjustable AIOL 100 can be implanted within the capsular bag 304(see FIGS. 3A and 3B) of the patient when positioned according to theconfiguration shown in FIG. 4A. The haptics 104 of the adjustable AIOL100 can be curved around a periphery of the optic portion 102 with thefree ends of the haptics 104 on almost opposing sides of the opticportion 102.

As shown in FIG. 4A, the expandable spacer 300 can also be curved suchthat a radially inward portion of the expandable spacer 300 follows ormatches a curvature of the optic portion 102. The expandable spacer 300can extend along almost an entire length of each of the haptics 104.

FIG. 4B illustrates that the expandable spacer 300 can extend radiallyinward from the radially inner portion 146 of the haptics 104 toward theoptic portion 102. In some embodiments, the expandable spacer 300 can beformed as a fin-like protrusion extending radially inward from theradially inner portion 146 of the haptics 104. In other embodiments, theexpand spacer 300 can be substantially shaped as discontinuous segmentsof an annulus positioned, at least partly, in between the optic portion102 and the haptics 104.

As illustrated in FIG. 4B, the expandable spacer 300 can have ananterior-to-posterior height. The anterior-to-posterior height of theexpandable spacer 300 can be significantly less than theanterior-to-posterior height of the haptic 104. Moreover, the expandablespacer 300 is relatively unconstrained in the anterior and posteriordirections such that any expansion of the spacer 300 primarily exerts aradially outward force or pressure on the haptics 104. Such expansionexerts relatively little force or pressure on the haptics 104 in theanterior-to-posterior direction.

In some embodiments, the expandable spacer 300 can have a spaceranterior-to-posterior height of between about 0.10 mm to about 1.00 mm.The expandable spacer 300 can also have a spacer radial width. Thespacer radial width can be between about 0.50 mm to about 1.0 mm. Incomparison, the haptic fluid chamber 120 can have a haptic fluid chamberanterior-to-posterior height of between about 2.0 mm to about 3.0 mm.Moreover, the haptic fluid chamber 120 can have a haptic fluid chamberradial width of between about 0.8 mm to about 1.1 mm.

FIGS. 5A and 5B illustrate sectional views of another embodiment of theadjustable AIOL 100 comprising an expandable spreader 500 made at leastin part of the composite material 200. The expandable spreader 500 canbe positioned or otherwise disposed in the radially inner portion 146 ofthe peripheral portion 103 (e.g., the haptic(s) 104, as shown in FIGS.5A and 5B). The radially inner portion 146 of the haptic(s) 104 can beradially thicker or bulkier than the radially outer portion 144.

As shown in FIGS. 5A and 5B, the expandable spreader 500 can bepositioned within a channel 502 or opening defined within the radiallyinner portion 146 of the haptic 104. In some embodiments, the channel502 or opening can extend along the entire length of the haptic 104. Inother embodiments, the channel 502 or opening can extend partly alongthe length of the haptic 104. The channel 502 or opening can be in fluidcommunication with the haptic fluid chamber 120.

In some embodiments, the expandable spreader 500 can occupy all of thespace within the channel 502 or opening except for a gap 504 or voidspace between the expandable spreader 500 and the outer peripheralsurface 142 of the optic portion 102. In further embodiments, the gap504 or void space can be replaced with the haptic material.

In other embodiments, the expandable spreader 500 can occupy at leastsome of the space within the channel 502 (for example, the expandablespreader 500 is positioned in a radially middle portion of the channel502 or opening). In these embodiments, a gap 504 or void space oradditional haptic material can separate (e.g., separate in a radialdirection) the expandable spreader 500 from the outer peripheral surface142 of the optic portion 102. In all such embodiments, the expandablespreader 500 can be located or positioned such that expansion of theexpandable spreader 500 does not cause the radially inner portion 146 ofthe haptic 104 or the expander spreader 500 to substantially impinge onor push against the outer peripheral surface 142 of the optic portion102 (thereby preventing the haptic(s) 104 from being pushed against thesides of the capsular bag 304, which can cause deformation of thehaptic(s) 104 and affect the volume of the haptic fluid chamber(s) 120).For example, the expandable spreader 500 can be located or positionedsuch that expansion of the expandable spreader 500 does not result inthe squeezing together or compression of the haptic chamber walls of thehaptic fluid chamber 120 (or does not result in the reduction of thevolume of the haptic fluid chamber 120).

In some embodiments, the expandable spreader 500 can be adhered to theradially inner portion 146 of the haptic 104 by being cured into placewithin the channel 502 or opening. For example, the expandable spreader500 can be adhered to a location or position at the middle portion ofthe channel 502 or opening.

In further embodiments, the expandable spreader 500 can refer to part ofthe peripheral portion 103 (e.g., part of the haptic 104) made of thecomposite material 200. For example, the expandable spreader 500 canrefer to part of the radially inner portion 146 of the haptic 104 madeof the composite material 200.

Although FIGS. 5A and 5B illustrate the expandable spreader 500 ashaving a rectangular cross-sectional profile, it is contemplated by thisdisclosure and it should be understood by one of ordinary skill in theart that the cross-sectional profile of the expandable spreader 500 canbe substantially shaped as an oval, a circle, triangular or otherpolygon.

FIGS. 5A and 5B illustrate that an external energy 302 can be directedor otherwise applied to the expandable spreader 500 to induce a shapechange in the expandable spreader 500 (e.g., enlarge the expandablespreader 500) to affect an optical parameter of the adjustable AIOL 100.

In some embodiments, the external energy 302 is light energy such as alaser light. In certain embodiments, the laser light can have awavelength between about 488 nm to about 650 nm. The external energy 302can be one or more bursts or pulses of laser light. In some embodiments,the laser light can be green laser light.

When the external energy 302 is light energy, the energy absorbingconstituents 204 can absorb or otherwise capture the light energy andconvert the light energy into thermal energy to cause the expandablecomponents 206 within the composite material 200 to expand.

As shown in FIG. 5B, the external energy 302 can cause the expandablespreader 500 to expand. Expansion of the expandable spreader 500 cancause the spreader 500 to push against channel walls 506 of the channel502 defined within the radially inner portion 146 of the haptic 104.

FIG. 5B illustrates that the enlarged spreader 500 can expand or spreadapart the channel walls 506 to expand or spread apart the channel 502.Moreover, the enlarged spreader 500 can also deform the chamber walls ofthe haptic fluid chamber 120 by spreading apart at least some of thechamber walls, thereby enlarging the volume of the haptic fluid chamber120.

The enlarged expandable spreader 500 can bias or push apart the channelwalls 506 of the channel 502, at least in an anterior-to-posteriordirection. This can result in an increase in the volume of the hapticfluid chamber 120. For example, FIG. 5B illustrates the spread apartchannel walls 506 and haptic chamber walls using solid lines and theposition of the channel walls 506 and haptic chamber walls prior toexpansion using broken-lines. FIG. 5B also illustrates that the gap 504or void space in between the spreader 500 and the optic portion 102allows the spreader 500 to expand or increase in size without causingthe spreader 500 to impinge on or push against the outer peripheralsurface 142 of the optic portion 102 (thereby preventing the haptic(s)104 from being pushed against the sides of the capsular bag 304, whichcan cause deformation of the haptic(s) 104 and affect the volume of thehaptic fluid chamber(s) 120). In other embodiments, additional hapticmaterial can separate the spreader 500 from the outer peripheral surface142 of the optic portion 102 such that expansion of the spreader 500only spreads apart the channel walls 506 and chamber walls and does notcause the radially outer portion 144 of the haptic(s) 104 to pushagainst the sides of the capsular bag 304.

As previously discussed, both the haptic fluid chamber(s) 120 and theoptic fluid chamber 110 can be filled with a fluid (e.g., silicone oil).Increasing the volume of the haptic fluid chamber 120 can cause at leastsome of the fluid within the optic fluid chamber 110 to flow from theoptic fluid chamber 110 into the haptic fluid chamber(s) 120. Moreover,as previously discussed, the haptic fluid chamber(s) 120 can be in fluidcommunication with the optic fluid chamber 120 through a plurality offluid channels 122 (including the first pair of fluid channels 122A, thesecond pair of fluid channels 122B, or a combination thereof, see FIG.1A). Although fluid flow between the haptic fluid chamber 120 and theoptic fluid chamber 120 is shown in FIG. 5B using the curved arrowdepicted using broken-lines, it should be understood by one of ordinaryskill in the art that fluid flows from the optic fluid chamber 110 tothe haptic fluid chamber(s) 120 via the plurality of fluid channels 122.

As previously discussed, the base power of the optic portion 102 can beconfigured to change based on an internal fluid pressure within thefluid-filled optic fluid chamber 110. The base power of the opticportion 102 can be configured to decrease as fluid enters the hapticfluid chamber(s) 120 from the optic fluid chamber 110.

The optic portion 102 can also be configured to change shape in responseto fluid exiting the optic fluid chamber 110. In certain embodiments,the anterior element 106 of the optic portion 102 can be configured tochange shape (e.g., decrease its curvature) in response to the fluidexiting the optic fluid chamber 110. In other embodiments, the posteriorelement 108 of the optic portion 102 can be configured to change shape(e.g., decrease its curvature) in response to the fluid exiting theoptic fluid chamber 110. In further embodiments, both the anteriorelement 106 and the posterior element 108 can be configured to changeshape in response to the fluid exiting the optic fluid chamber 110. Thebase power of the optic portion 102 can be configured to decrease inresponse to the shape change(s) undertaken by the anterior element 106,the posterior element 108, or a combination thereof.

As depicted in FIGS. 5A and 5B, applying an external energy 302 to theexpandable spreader 500 (e.g., when the expandable spreader 500 ispositioned within a channel 502 or opening defined within the radiallyinner portion 146 of the haptic(s) 104) can cause the volume of thehaptic fluid chamber(s) 120 to increase. This increase in the volume ofthe haptic fluid chamber(s) 120 can draw fluid out of the optic fluidchamber 110 and cause a decrease in the base power of the adjustableAIOL 100.

For example, a method of decreasing a base power of the adjustable AIOL100 can comprise directing or applying an external energy 302 (e.g.,light energy between about 520 nm to about 570 nm) at an expandablespreader 500 embedded within the adjustable AIOL 100 implanted within aneye of the patient. More specifically, the external energy 302 can beapplied or directed at an expandable spreader 500 made in part of thecomposite material 200. The expandable spreader 500 can expand inresponse to the application of the external energy 302. Expansion of thespreader 500 can result in the volume of the haptic fluid chamber(s) 120being enlarged. Fluid within the optic fluid chamber 110 can then flowinto the haptic fluid chamber(s) 110 in response to this increase in thevolume of the haptic fluid chamber(s) 120. The base power of the opticportion 102 can decrease in response to this fluid flow out of the opticfluid chamber 110.

In some embodiments, bursts or pulses of external energy 302 (e.g.,light energy) directed at the expandable spreader 500 can result in adecrease in the base power of the adjustable AIOL 100 by between about−0.10 D and about −0.20 D (e.g., about −0.125 D). For example, pulses ofgreen laser light directed at the expandable spreader 500 can result ina decrease in the base power of the adjustable AIOL 100 by between about−0.10 D and about −0.20 D (e.g., about −0.125 D). In some embodiments,the base power of the adjustable AIOL 100 can decrease between about−1.0 D to about −5.0 D (e.g., about −2.0 D) in total in response tobursts or pulses of the external energy 302 directed at the expandablespreader 500.

FIG. 6 illustrates a sectional view of another embodiment of theadjustable AIOL 100 comprising an expandable protuberance 600 made atleast in part of the composite material 200. The expandable protuberance600 can be positioned or otherwise disposed along part of the radiallyinner portion 146 of the peripheral portion 103 (e.g., the one or morehaptics 104) of the adjustable AIOL 100.

As shown in FIG. 6, the haptic 104 (e.g., any of the first haptic 104Aor the second haptic 104B) can comprise haptic chamber walls surroundingthe haptic fluid chamber 120. For example, the haptic chamber walls cancomprise a radially inner wall 602 and radially outer wall 604. Thehaptic fluid chamber 120 can be defined in part by the radially innerwall 602 and the radially outer wall 604.

The expandable protuberance 600 can be positioned or otherwise disposedalong part of the radially inner wall 602 of the haptic 104. Morespecifically, the expandable protuberance 600 can be positioned orotherwise disposed or affixed along a radially outermost portion 606 ofthe radially inner wall 602 of the haptic 104.

In some embodiments, the adjustable AIOL 100 can be designed such that agap or void space 608 radially separates the radially inner wall 602 ofthe haptic 104 from the outer peripheral surface 142 of the opticportion 102. This can ensure that neither the expandable protuberance600 nor the radially inner wall 602 impinges or pushes against the outerperipheral surface 142 of the optic portion 102 when the expandableprotuberance 600 expands (thereby preventing the haptic(s) 104 frombeing pushed against the sides of the capsular bag 304, which can causedeformation of the haptic(s) 104 and affect the volume of the hapticfluid chamber(s) 120). As previously discussed, when the radially innerportion 146 of the haptic 104 pushes against the outer peripheralsurface 142 of the optic portion 102, the haptic chamber walls cancompress or squeeze together as a result of the radially outer wall 604of the haptic 104 pressing against the sides of the capsular bag 304 ofthe patient. In other embodiments, the adjustable AIOL 100 can bedesigned such that the radially inner wall 602 of the haptic 104continuously rests against the outer peripheral surface 142 of the opticportion 102 or intermittently rests against the outer peripheral surface142 of the optic portion 102.

In some embodiments, for example, as shown in FIG. 6, the entireexpandable protuberance 600 can be positioned below (or above) a halfwayline or haptic midline 610. The halfway line or haptic midline 610 canbisect the anterior-to-posterior height of the haptic 104 In theseembodiments, no part of the expandable protuberance 600, in anunexpanded state, can extend beyond the haptic midline 610. Ananterior-to-posterior height of the expandable protuberance 600 can beless than the anterior-to-posterior height of the radially inner wall602.

In some embodiments, the expandable protuberance 600 can be adhered tothe radially inner portion 146 (e.g., the radially inner wall 602) ofthe haptic 104 by being cured into place. For example, the expandableprotuberance 600 can be adhered to a cavity, furrow, or groove formedalong the radially outermost portion 606 of the radially inner wall 602.In these instances, the expandable protuberance 600 can take up oroccupy less than half the anterior-to-posterior height of the radiallyinner wall 602.

In further embodiments, the expandable protuberance 600 can refer topart of the radially inner portion 146 (e.g., part of the radially innerwall 602) made of the composite material 200. For example, theexpandable protuberance 600 can refer to a part of the radiallyoutermost portion 606 of the radially inner wall 602 made of thecomposite material 200.

Although FIG. 6 illustrates the cross-sectional profile of theexpandable protuberance 600 as having primarily straight edges andcorners, it is contemplated by this disclosure and it should beunderstood by one of ordinary skill in the art that the cross-sectionalprofile of the expandable protuberance 600 can also have rounded orcurved edges and corners.

FIG. 6 also illustrate that an external energy 302 can be directed orotherwise applied to the expandable protuberance 600 to induce a shapechange in the expandable protuberance 600 (e.g., enlarge the expandableprotuberance 600) to affect an optical parameter of the adjustable AIOL100.

The external energy 302 can be the same external energy 302 aspreviously disclosed. For example, when the external energy 302 is lightenergy, the energy absorbing constituents 204 can absorb or otherwisecapture the light energy and convert the light energy into thermalenergy to cause the expandable components 206 within the compositematerial 200 to expand.

As shown in FIG. 6, the external energy 302 can cause the expandableprotuberance 600 to expand (as depicted by the enlarged protuberance 600shown in broken lines). Expansion of the expandable protuberance 600 cancause the protuberance 600 to encroach, extend, or otherwise grow intothe fluid-filled haptic fluid chamber 120. This can cause fluid withinthe haptic fluid chamber 120 to be displaced or pushed into the opticfluid chamber 110 (through the plurality of fluid channels 122).Moreover, when the protuberance 600 expands and part of the protuberance600 encroaches, extends, or grows into the haptic fluid chamber 120, thefluid carrying capacity or the available volume of the haptic fluidchamber 120 can decrease.

As previously discussed, both the haptic fluid chamber(s) 120 and theoptic fluid chamber 110 can be filled with a fluid (e.g., silicone oil).Reducing the fluid carrying capacity or the available volume of thehaptic fluid chamber 120 can cause at least some of the fluid within thehaptic fluid chamber(s) 120 to flow from the haptic fluid chamber(s) 120into the optic fluid chamber 120, and remain in the optic fluid chamber120. Although fluid flow between the haptic fluid chamber 120 and theoptic fluid chamber 120 is shown in FIG. 6 using the curved arrowdepicted using broken-lines, it should be understood by one of ordinaryskill in the art that fluid flows from the haptic fluid chamber(s) 120to the optic fluid chamber 120 via the plurality of fluid channels 122.

As previously discussed, the base power of the optic portion 102 can beconfigured to change based on an internal fluid pressure within thefluid-filled optic fluid chamber 110. The base power of the opticportion 102 can be configured to increase as fluid enters the opticfluid chamber 110 from the haptic fluid chamber(s) 120.

The optic portion 102 can also be configured to change shape in responseto fluid entering the optic fluid chamber 110. In certain embodiments,the anterior element 106 of the optic portion 102 can be configured tochange shape (e.g., increase its curvature) in response to the fluidentering the optic fluid chamber 110. In other embodiments, theposterior element 108 of the optic portion 102 can be configured tochange shape (e.g., increase its curvature) in response to the fluidentering the optic fluid chamber 110. In further embodiments, both theanterior element 106 and the posterior element 108 can be configured tochange shape in response to the fluid entering the optic fluid chamber110. The base power of the optic portion 102 can be configured toincrease in response to the shape change(s) undertaken by the anteriorelement 106, the posterior element 108, or a combination thereof.

In some embodiments, bursts or pulses of external energy 302 (e.g.,light energy) directed at the expandable protuberance 600 can result inan increase in the base power of the adjustable AIOL 100 by betweenabout +0.10 D and about +0.20 D (e.g., about +0.125 D). For example,pulses of green laser light directed at the expandable protuberance 600can result in an increase in the base power of the adjustable AIOL 100by between about +0.10 D and about +0.20 D (e.g., about +0.125 D). Insome embodiments, the base power of the adjustable AIOL 100 can increasebetween about +1.0 D to about +5.0 D (e.g., about +2.0 D) in total inresponse to bursts or pulses of the external energy 302 directed at theexpandable protuberance 600.

FIGS. 7A and 7B illustrate top and sectional views, respectively, ofanother embodiment of the adjustable AIOL 100 comprising both anexpandable spreader 500 and an expandable protuberance 600 making up atleast part of each of the haptics 104. For example, as shown in FIG. 7A,a first haptic portion made of the expandable spreader 500 can bepositioned or adhered to one part of the haptic chamber wall and asecond haptic portion made of the expandable protuberance 600 can bepositioned or adhered to another part of the same haptic chamber wall.

In some embodiments, the first haptic portion (e.g., the expandablespreader 500) can be made in part of a first composite material, or afirst type of the composite material 200 shown in FIG. 2A, and thesecond haptic portion (e.g., the expandable protuberance 600) can bemade in part of a second composite material, or a second type of thecomposite material 200 shown in FIG. 2A.

In some embodiments, the first composite material can be made in part ofa first energy absorbing constituent (e.g., a first type of the energyabsorbing constituent 204 shown in FIG. 2A) and the second compositematerial can be made in part of a second energy absorbing constituent(e.g., a second type of the energy absorbing constituent 204 shown inFIG. 2A). For example, the first composite material can be made in partof Disperse Red 1 dye and the second composite material can be made inpart of graphitized carbon black. The first energy absorbing constituentcan have or exhibit a first color (e.g., the Disperse Red 1 dye can haveor exhibit a red color) and the second energy absorbing constituent canhave or exhibit a second color (e.g., the graphitized carbon black canhave or exhibit a black color) different from the first color. Also, asanother example, the first energy absorbing constituent can be an azodye having a first color (e.g., Disperse Red 1 dye) and the secondenergy absorbing constituent can be another azo dye having a secondcolor (e.g., Disperse Orange 1 dye). This difference in color can allowa clinician or another medical professional to visually differentiatebetween the two haptic portions.

In certain embodiments, the first composite material made in part of thefirst energy absorbing constituent can expand in response to a firsttype of external energy (e.g., light energy between 520 nm to 540 nm)directed at the first composite material and the second compositematerial made in part of the second energy absorbing constituent canexpand in response to a second type of external energy (e.g., lightenergy between 600 nm and 650 nm) directed at the second energyabsorbing constituent. In these and other embodiments, the first energyabsorbing constituent can have or exhibit a first color (e.g., redcolor) and the second energy absorbing constituent can have or exhibit asecond color (e.g., an orange or blue color) different from the firstcolor.

In other embodiments, the first composite material and the secondcomposite material can be made in part of the same energy absorbingconstituents but comprise different amounts or weight percentages ofsuch constituents. In other embodiments, the first composite materialand the second composite material can be made in part of the same energyabsorbing constituents but comprise different amounts or weightpercentages of expandable components 206.

As shown in FIG. 7A, the first haptic portion made in part of the firstcomposite material can be positioned or located radially offset from thesecond haptic portion made in part of the second composite material. Forexample, the expandable spreader 500 can be positioned radially offsetfrom the expandable protuberance 600 on each of the haptics 104. Morespecifically, a radially innermost portion of the haptic 104 can be madein part of the expandable spreader 500 and an adjoining portion of thehaptic radially outward from the expandable spreader 500 can be made inpart of the expandable protuberance 600.

Also, as shown in FIG. 7A, the expandable spreader 500 can extend alongpart of a length of the haptic 104. Moreover, the expandableprotuberance 600 can also extend along part of the length of the haptic104.

FIG. 7B illustrates that the same radially inner wall 602 of the haptic104 can comprise both an expandable spreader 500 and an expandableprotuberance 600. In the embodiment shown in FIG. 7B, the expandablespreader 500 can be made in part of a first composite material (e.g., acomposite material 200 comprising a first energy absorbing colorant) andthe expandable protuberance 600 can be made in part of a secondcomposite material (e.g., a composite material 200 comprising a secondenergy absorbing colorant). The difference in the color of the energyabsorbing colorants can allow a clinician or another medicalprofessional to more easily distinguish the expandable spreader 500 andthe expandable protuberance 600. In other embodiments (for example, asdepicted in FIG. 9B), the expandable spreader 500 and the expandableprotuberance 600 can be made of the same composite material 200.

The expandable spreader 500 can be positioned within a channel 502 oropening defined within the radially inner wall 602. The channel 502 oropening can be in fluid communication with the haptic fluid chamber 120.

In some embodiments, the expandable spreader 500 can occupy a radiallyinnermost portion 700 of the radially inner wall 602 of the haptic 104.In these embodiments, the expandable spreader 500 can also occupy or bedisposed at a radially innermost end of the channel 502. In furtherembodiments, the expander spreader 500 can refer to part of a hapticchamber wall of the haptic 104 made of the composite material 200. Forexample, in these embodiments, the expander spread 500 can refer to partof the radially innermost portion 700 of the radially inner wall 602 ofthe haptic 104 made of the composite material 200.

As shown in FIG. 7B, a void space 608 or gap can separate the radiallyinnermost portion 700 of the radially inner wall 602 of the haptic 104from the outer peripheral surface 142 of the optic portion 102. This canallow the expandable spreader 500 to expand without impinging on orpushing up against the outer peripheral surface 142 of the optic portion102.

As further shown in FIG. 7B, the expandable protuberance 600 can bepositioned or otherwise disposed or affixed along a radially outermostportion 606 of the radially inner wall 602 of the haptic 104. In certainembodiments, the expandable protuberance 600 can refer to part of thehaptic chamber wall made of the composite material 200. For example, theexpandable protuberance 600 can refer to part of the radially outermostportion 606 of the radially inner wall 602 of the haptic 104 made of thecomposite material 200.

External energy 302 directed or otherwise applied to the expanderspreader 500 positioned along the haptic chamber wall (e.g., positionedalong the radially innermost portion 700 of the radially inner wall 602of the haptic 104) can cause the expandable spreader 500 to expand.Expansion of the expandable spreader 500 can cause the spreader 500 topush against the channel walls 506 of the channel 502 and enlarge atleast one of the channel 502 and the haptic fluid chamber 120. This cancause the volume of the haptic fluid chamber(s) 120 to increase. Thiscan then draw fluid out of the optic fluid chamber 110 into the hapticfluid chamber(s) 120 (via the fluid channels 122) and cause a decreasein the base power of the adjustable AIOL 100 (e.g., a decrease betweenabout −0.10 D and −0.20 D).

The same external energy 302 or another type of external energy 302(e.g., light energy of another wavelength) can also be directed orotherwise applied to the expandable protuberance 600 positioned alongthe haptic chamber wall (e.g., positioned along the radially outermostportion 606 of the radially inner wall 602 of the haptic 104). Theexternal energy can cause the expandable protuberance 600 to expand.Expansion of the expandable spreader 500 can cause the protuberance 600to encroach, extend, or otherwise grow into the fluid-filled hapticfluid chamber 120. This can cause fluid within the haptic fluid chamber120 to be displaced or pushed into the optic fluid chamber 110 (throughthe plurality of fluid channels 122). Bursts or pulses of externalenergy 302 (e.g., light energy) directed at the expandable protuberance600 can result in an increase in base power of the adjustable AIOL 100by between about +0.10 D and +0.20 D.

FIG. 8 illustrates a top plan view of another embodiment of theadjustable AIOL 100 comprising both expandable spreaders 500 andexpandable protuberances 600 implemented as discrete components 800along the haptics 104. In alternative embodiments, at least one of theexpandable spreaders 500 and the expandable protuberances 600 can bereplaced with expandable spacers 300 (see FIGS. 3A and 3B).

In some embodiments, the expandable spreaders 500 can occupy or bepositioned along a radially innermost portion 700 (see, FIG. 7B) of theradially inner wall 602 of the haptic(s) 104. The expandableprotuberances 600 can occupy or be positioned along a radially outermostportion 606 (see, FIG. 6) of the radially inner wall 602 of thehaptic(s) 104.

At least one of the expandable spreaders 500 and the expandableprotuberances 600 can be implemented or configured as discretecomponents 800 visually perceptible to a clinician or another medicalprofessional responsible for adjusting the adjustable AIOL 100 when theadjustable AIOL 100 is implanted within an eye of a patient.

The discrete components 800 can refer to a shape or configuration of theexpandable spreaders 500, the expandable protuberances 600, or acombination thereof. In some embodiments, the discrete components 800can have a circular profile when viewed from the top down or when viewedin an anterior to posterior direction. In these embodiments, each of thediscrete components 800 can be shaped substantially as a cylinder. Inother embodiments not shown in the figures, the discrete components 800can have an oval profile, a rectangular profile, a triangular profile, adiamond or rhombus profile, a star profile, any other polygonal profile,or a combination thereof when viewed from the top down or when viewed inan anterior to posterior direction. The discrete components 800 can bespaced close apart or each of the discrete components 800 can beseparated from one another by portions of the haptic material.

Moreover, as shown in FIG. 8, a portion or segment of one haptic 104 cancomprise the expandable spreaders 500 and another portion or segment ofthe same haptic 104 can comprise the expandable protuberances 600. Forexample, a distal segment 802 of each of the haptics 104 (e.g., asegment 802 closer to the closed free end 138 of the haptics 104) cancomprise the expandable spreaders 500 and a proximal segment 804 of eachof the haptics 104 (e.g., a segment 804 closer to the optic portion 102)can comprise the expandable protuberances 600. As shown in FIG. 8, theexpandable protuberances, implemented as discrete components 800, can beradially offset or radially separated from the expandable spreaders 500,also implemented as discrete components 800.

Designing or otherwise configuring at least one of the expandablespreaders 500 and the expandable protuberances 600 as discretecomponents 800 can allow a clinician or medical professional to finetune the adjustment of the adjustable AIOL 100. For example, theclinician or medical professional can direct the external energy 302 atone of the discrete components 800 to either increase the base power ofthe adjustable AIOL 100 (when the discrete component 800 is anexpandable protuberance 600) or decrease the base power of theadjustable AIOL 100 (when the discrete component 800 is an expandablespreader 500) by a set amount. More specifically, in certainembodiments, the discrete components 800 can be sized, shaped, orlocated to allow bursts or pulses of the external energy 302 applied toeach of the discrete components 800 to adjust an optical parameter(e.g., a base power) of the adjustable AIOL 100 by a predetermined orpreset amount. For example, bursts or pulses of the external energy 302applied to or directed at each of the discrete components 800 can causea change in the base power by about ±0.10 D and ±0.20 D (e.g., about±0.125 D).

Moreover, in this example, the clinician or medical professional canalso direct further bursts or pulses of the external energy 302 at thesame discrete component 800 to further increase or decrease the basepower of the adjustable AIOL 100 or direct further bursts or pulses ofthe external energy 302 at a different discrete component 800 to undo ornegate a previous adjustment (for example, to decrease the base powerafter an increase of the base power has been induced).

Although FIG. 8 illustrates the haptic(s) 104 comprising both theexpandable spreaders 500 and the expandable protuberances 600(configured as discrete components 800), it is contemplated by thisdisclosure and it should be understood by one of ordinary skill in theart that each of the haptics 104 can also comprise only the expandablespreaders 500 or only the expandable protuberances 600 as discretecomponents 800.

As shown in FIGS. 7A, 7B, and 8, the adjustable AIOL 100 can beconfigured such that a base power of the adjustable AIOL 100 can beadjusted in a first manner (e.g., increasing the base power) bydirecting or otherwise applying an external energy 302 at a firstportion of the haptic 104 made in part of the composite material 200.Moreover, the base power of the adjustable AIOL 100 can be adjusted in asecond manner (e.g., decreasing the base power) by directing orotherwise applying additional bursts or pulses of the external energy302 at a second portion of the same or different haptic 104 made in partof the composite material 200. In some embodiments, the compositematerial 200 used to make the first portion of the haptic 104 can be orexhibit a different color than the composite material 200 used to makethe second portion of the haptic 104 as a result of differences in theenergy absorbing constituents 204 making up the composite materials 200.

FIG. 9A illustrates a top plan view of another embodiment of theadjustable AIOL 100 comprising both expandable spreaders 500 andexpandable protuberances 600 arranged in a visually perceptible pattern900. The visually perceptible pattern 900 can allow a clinician ormedical professional responsible for post-operatively adjusting theadjustable AIOL 100 to distinguish between the expandable spreaders 500and the expandable protuberances 600, especially when the expandablespreaders 500 and the expandable protuberances 600 are made from thesame composite material 200 having the same color (as shown in FIG. 9A).This can allow the clinician or medical professional to more easilydetermine where to direct or apply the external energy 302 on theadjustable AIOL 100 in order to adjust an optical parameter of theadjustable AIOL 100.

As shown in FIG. 9A-9C, the visually perceptible pattern 900 can includeboth a continuous curved segment of the expandable protuberance 600 andspaced-apart branches or finger-shaped segments of the expandablespreaders 500 extending radially inward from the continuous curvedsegment. FIG. 9A also illustrates that the branches or finger-shapedsegments of the expandable protuberance 600 can be separated from oneanother by portions of haptic material 902. The haptic material 902 canbe the same haptic material used to construct the remainder of thehaptic(s) 104. For example, the visually perceptible pattern 900 can bea comb-shaped pattern. In other embodiments, the visually perceptiblepattern 900 can be a wave pattern, a chained-triangular pattern, azig-zag pattern, or a combination thereof.

For example, a clinician or another medical professional can direct orotherwise apply the external energy 302 at the spaced-apart branches orfinger-shaped segments to expand the expandable spreaders 500 in orderto decrease the base power of the adjustable AIOL 100. The clinician ormedical professional can also direct or otherwise apply the externalenergy 302 at the expandable protuberance 600 shaped as the curvedportion positioned radially outward of the spaced-apart branches orfinger-shaped segments to expand the expandable protuberance 600 inorder to increase the base power of the adjustable AIOL 100.

FIG. 9B illustrates a sectional view of the embodiment of the adjustableAIOL 100 shown in FIG. 9A taken along cross-section A-A. As shown inFIG. 9B, this section of the haptic 104 can comprise both the expandablespreader 500 and the expandable protuberance 600 adhered, formed, orotherwise positioned along the radially inner wall 602. The expandablespreaders 500 can be positioned along the radially innermost portion 700of the radially inner wall 602 or at a radially innermost end of achannel 502 defined along the radially inner wall 602. The expandableprotuberance 600 can be positioned along a radially outermost portion606 of the radially inner wall 602 of the haptic 104. The expandableprotuberance 600 can be positioned underneath or further posterior ofthe expandable spreader 500. Moreover, the adjustable AIOL 100 can beconfigured such that a void space 608 or gap separates the radiallyinner wall 602 of the haptic 104 from the outer peripheral surface 142of the optic portion 102 such that expansion of the expandable spreader500 does not cause any part of the haptic 104 to substantially impingeon or push up against the outer peripheral surface 142 of the opticportion 102 (thereby preventing the haptic(s) 104 from being pushedagainst the sides of the capsular bag 304, which can cause deformationof the haptic(s) 104 and affect the volume of the haptic fluidchamber(s) 120).

FIG. 9C illustrates a sectional view of the embodiment of the adjustableAIOL 100 shown in FIG. 9A taken along cross-section B-B. As shown inFIG. 9C, this section of the haptic 104 can comprise only the expandableprotuberance 600 adhered, formed, or otherwise positioned along theradially inner wall 602. The expandable protuberance 600 can bepositioned along a radially outermost portion 606 of the radially innerwall 602 of the haptic 104. The remainder of the radially inner wall 602can be made of the same haptic material 902 used to construct the restof the haptic 104.

The visually perceptible pattern 900 can allow a clinician or medicalprofessional to more easily determine where to direct or apply theexternal energy 302 on the adjustable AIOL 100 in order to adjust anoptical parameter of the adjustable AIOL 100. This can be useful whenboth the expandable spreaders 500 and the expandable protuberances 600are made of the same composite material 200 having or exhibiting thesame color. The clinician or medical professional can direct orotherwise apply the external energy 302 exclusively at the expandableprotuberance 600 shaped as the curved portion to expand the expandableprotuberance 600 in order to increase the base power of the adjustableAIOL 100. The clinician or medical professional can also direct orotherwise apply the external energy 302 exclusively at the branches orfinger-shaped portion to expand the expandable spreaders 500 in order todecrease the base power of the adjustable AIOL 100.

One technical problem faced by the applicants is how to integrate thecomposite material with the rest of the adjustable AIOL withoutinterfering with the optical quality of the lens. One solutiondiscovered by the applicants and disclosed herein is to position orembed the composite material within or along the haptic chamber walls.More specifically, the solution discovered by the applicants is toposition or embed the composite material along or within the radiallyinner wall of the haptic(s).

FIG. 10 illustrates a sectional view of an optic portion 102 of anotherembodiment of the adjustable AIOL 100 comprising an adhesive layer 1000made in part of the composite material 200. In some embodiments, theadhesive layer 1000 can comprise the composite material 200 integratedor mixed with the adhesives 148 previously discussed. In otherembodiments, the composite material 200 can be positioned or sandwichedin between layers of the adhesive 148.

The adhesive layer 1000 can be positioned or disposed along theperipheral edge 150 of the posterior element 108 (i.e., the top of theraised inner surface 132). Although FIG. 10 illustrates the adhesivelayer 1000 as being located along opposing sides of the optic portion102, it should be understood by one of ordinary skill in the art thatthe adhesive layer 1000 extends circumferentially around the entireperiphery of the optic portion 102. The adhesive layer 1000 can also bereferred to as rotationally symmetric.

In some embodiments, the base power of the adjustable AIOL 100 can beconfigured to decrease in response to an external energy 302 directed orotherwise applied at the adhesive layer 1000. The adhesive layer 10000can be configured to expand in response to the external energy 302directed at the adhesive layer 1000. The external energy 302 can bedirected at the entire adhesive layer 1000 surrounding the periphery ofthe optic portion 102.

Expansion of the adhesive layer 1000 can raise the anterior element 106and increase the volume of the optic fluid chamber 110. This can causethe anterior element 106 to flatten slightly as the internal fluidpressure within the fluid-filled optic fluid chamber 110 decreases.

In some embodiments, bursts or pulses of external energy 302 (e.g.,light energy) directed at the adhesive layer 1000 can result in adecrease in base power of the adjustable AIOL 100 by between about −0.10D and −0.20 D (e.g., about −0.125 D). For example, pulses of green laserlight directed at the adhesive layer 1000 can result in a decrease inthe base power of the adjustable AIOL 100 by between about −0.10 D and−0.20 D (e.g., about −0.125 D). In some embodiments, the base power ofthe adjustable AIOL 100 can decrease between about −1.0 D to about −5.0D (e.g., about −2.0 D) in total in response to bursts or pulses of theexternal energy 302 directed at the adhesive layer 1000.

FIG. 11 illustrates a perspective view of another embodiment of theadjustable AIOL 100 comprising an adjustable anterior element 1100having the composite material 200 located or positioned alongdiametrically opposed peripheral portions of the anterior element 1100.As shown in FIG. 11, the composite material 200 can be shaped orconfigured as a number of discrete components 800 arranged on opposingperipheral edges of the anterior element 1100.

For example, the composite material 200 can be shaped or configured as aplurality of discrete components 800 lined up along a first peripheraledge 1102 and a second peripheral edge 1104 of the anterior element1100. The first peripheral edge 1102 can be located diametricallyopposed to or separated by about 180 degrees from the second peripheraledge 1104. In all such embodiments, the composite material 200 does notextend along the entire circumference or surround the entire peripheryof the anterior element 1100.

In some embodiments, the composite material 200 can be located oradhered in between the anterior optical surface 112 and the anteriorinner surface 114. In other embodiments, the composite material 200 canextend out or protrude partly from the anterior optical surface 112. Thecomposite material 200 can be visually perceptible to a clinician oranother medical professional when the adjustable AIOL 100 is implantedwithin an eye of a patient. For example, the composite material 200 canbe made in part of an energy absorbing constituent 204 or coloranthaving or exhibiting a color (e.g., red-color or black-color) that isvisually perceptible to the clinician or another medical professional.

The clinician or another medical professional can direct or otherwiseapply an external energy 302 to the composite material 200 (for example,to all of the composite material 200 shaped or configured as discretecomponents 800 along the first peripheral edge 1102 and the secondperipheral edge 1104). The composite material 200 can expand in responseto this application of external energy 302. This expansion or swellingof the composite material 200 can cause the anterior optical surface 112of the anterior element 1100 to flatten or exhibit a flatter curvaturealong a first meridian (referred to as a flat meridian 1106) of theanterior element 1100. The flat meridian 1106 can be substantiallyperpendicular to another meridian (referred to as a steep meridian 1108)of the anterior element 1100 where the curvature of the anterior element1100 along this other meridian is substantially unaffected by theexpansion of the composite material 200. In this manner, a cylinder orcylindricity is induced on the anterior optical surface 112 of theanterior element 1100. This change in the cylindricity of the anteriorelement 1100 can persist or remain substantially permanent even afterthe external energy 302 is no longer directed or applied to the anteriorelement 1100.

More specifically, in response to the application of the external energy302, the radius of curvature of the anterior optical surface 112measured along the flat meridian 1106 can be greater than the radius ofcurvature of the anterior optical surface 112 measured along the steepmeridian 1108. Moreover, in response to the application of the externalenergy 302, a peripheral thickness of the anterior element 1100 alongthe flat meridian 1106 can be greater than a peripheral thickness of theanterior element 1100 along the steep meridian 1108.

In some embodiments, applying or directing the external energy 302 atthe composite material 200 can induce the anterior element 1100 to havea cylinder power between about +0.50 D to about +5.0 D (e.g., about+1.50 D or about +3.0 D). The cylinder power can be measured along thesteep meridian 1108 of the anterior element 1100.

Although FIG. 11 illustrates an adjustable AIOL 100 comprising anadjustable anterior element 1100 having the composite material 200, itis contemplated by this disclosure that the adjustable AIOL 100 can alsocomprise an adjustable posterior element having the composite material200. For example, the composite material 200 can be located orpositioned along diametrically opposed peripheral portions of theposterior element. The composite material 200 can be shaped orconfigured as a number of discrete components 800 arranged on opposingperipheral edges of the posterior element.

In some embodiments, the composite material 200 can be located oradhered in between the posterior optical surface 116 and the posteriorinner surface 118 (see, for example, FIGS. 1B and 1C). In otherembodiments, the composite material 200 can extend out or protrudepartly from the posterior optical surface 116. The composite material200 can be visually perceptible to a clinician or another medicalprofessional when the adjustable AIOL 100 is implanted within an eye ofa patient.

The clinician or another medical professional can direct or otherwiseapply an external energy 302 to the composite material 200 making uppart of the peripheral edges of the posterior element. The compositematerial 200 can expand in response to this application of externalenergy 302. This expansion or swelling of the composite material 200 cancause the posterior optical surface 116 to flatten or exhibit a flattercurvature along a flat meridian of the posterior element. The flatmeridian can be substantially perpendicular to a steep meridian of theposterior element where the curvature of the posterior element along thesteep meridian is substantially unaffected by the expansion of thecomposite material 200. In this manner, a cylinder or cylindricity isinduced on the posterior optical surface 116 of the posterior element.This change in the cylindricity of the posterior element can persist orremain substantially permanent even after the external energy 302 is nolonger directed or applied to the posterior element.

More specifically, in response to the application of the external energy302, the radius of curvature of the posterior optical surface 116measured along the flat meridian can be greater than the radius ofcurvature of the posterior optical surface 116 measured along the steepmeridian. Moreover, in response to the application of the externalenergy 302, a peripheral thickness of the posterior element along theflat meridian can be greater than a peripheral thickness of theposterior element along the steep meridian.

In some embodiments, applying or directing the external energy 302 atthe composite material 200 can induce the posterior element to have acylinder power between about +0.5 D to about +5.0 D (e.g., about +1.5 Dor about +3.0 D). The cylinder power can be measured along the steepmeridian of the posterior element.

One technical problem faced by the applicants is how to inducecylindricity or cylinder in an accommodating intraocular lens withoutinterfering with the optical quality of the lens. One solutiondiscovered by the applicants and disclosed herein is to position orembed the composite material along or within the peripheral edges of anoptical element (e.g., the anterior element, the posterior element, or acombination thereof). More specifically, the solution discovered by theapplicants is to position or embed the composite material along orwithin part of two diametrically opposed peripheral edges of at leastone of the anterior element and the posterior element.

A number of embodiments have been described. Nevertheless, it will beunderstood by one of ordinary skill in the art that various changes andmodifications can be made to this disclosure without departing from thespirit and scope of the embodiments. Elements of systems, devices,apparatus, and methods shown with any embodiment are exemplary for thespecific embodiment and can be used in combination or otherwise on otherembodiments within this disclosure. For example, the steps of anymethods depicted in the figures or described in this disclosure do notrequire the particular order or sequential order shown or described toachieve the desired results. In addition, other steps operations may beprovided, or steps or operations may be eliminated or omitted from thedescribed methods or processes to achieve the desired results. Moreover,any components or parts of any apparatus or systems described in thisdisclosure or depicted in the figures may be removed, eliminated, oromitted to achieve the desired results. In addition, certain componentsor parts of the systems, devices, or apparatus shown or described hereinhave been omitted for the sake of succinctness and clarity.

Accordingly, other embodiments are within the scope of the followingclaims and the specification and/or drawings may be regarded in anillustrative rather than a restrictive sense.

Each of the individual variations or embodiments described andillustrated herein has discrete components and features which may bereadily separated from or combined with the features of any of the othervariations or embodiments. Modifications may be made to adapt aparticular situation, material, composition of matter, process, processact(s) or step(s) to the objective(s), spirit or scope of the presentinvention.

Methods recited herein may be carried out in any order of the recitedevents that is logically possible, as well as the recited order ofevents. Moreover, additional steps or operations may be provided orsteps or operations may be eliminated to achieve the desired result.

Furthermore, where a range of values is provided, every interveningvalue between the upper and lower limit of that range and any otherstated or intervening value in that stated range is encompassed withinthe invention. Also, any optional feature of the inventive variationsdescribed may be set forth and claimed independently, or in combinationwith any one or more of the features described herein. For example, adescription of a range from 1 to 5 should be considered to havedisclosed subranges such as from 1 to 3, from 1 to 4, from 2 to 4, from2 to 5, from 3 to 5, etc. as well as individual numbers within thatrange, for example 1.5, 2.5, etc. and any whole or partial incrementstherebetween.

All existing subject matter mentioned herein (e.g., publications,patents, patent applications) is incorporated by reference herein in itsentirety except insofar as the subject matter may conflict with that ofthe present invention (in which case what is present herein shallprevail). The referenced items are provided solely for their disclosureprior to the filing date of the present application. Nothing herein isto be construed as an admission that the present invention is notentitled to antedate such material by virtue of prior invention.

Reference to a singular item, includes the possibility that there areplural of the same items present. More specifically, as used herein andin the appended claims, the singular forms “a,” “an,” “said” and “the”include plural referents unless the context clearly dictates otherwise.It is further noted that the claims may be drafted to exclude anyoptional element. As such, this statement is intended to serve asantecedent basis for use of such exclusive terminology as “solely,”“only” and the like in connection with the recitation of claim elements,or use of a “negative” limitation. Unless defined otherwise, alltechnical and scientific terms used herein have the same meaning ascommonly understood by one of ordinary skill in the art to which thisinvention belongs.

Reference to the phrase “at least one of”, when such phrase modifies aplurality of items or components (or an enumerated list of items orcomponents) means any combination of one or more of those items orcomponents. For example, the phrase “at least one of A, B, and C” means:(i) A; (ii) B; (iii) C; (iv) A, B, and C; (v) A and B; (vi) B and C; or(vii) A and C.

In understanding the scope of the present disclosure, the term“comprising” and its derivatives, as used herein, are intended to beopen-ended terms that specify the presence of the stated features,elements, components, groups, integers, and/or steps, but do not excludethe presence of other unstated features, elements, components, groups,integers and/or steps. The foregoing also applies to words havingsimilar meanings such as the terms, “including”, “having” and theirderivatives. Also, the terms “part,” “section,” “portion,” “member”“element,” or “component” when used in the singular can have the dualmeaning of a single part or a plurality of parts. As used herein, thefollowing directional terms “forward, rearward, above, downward,vertical, horizontal, below, transverse, laterally, and vertically” aswell as any other similar directional terms refer to those positions ofa device or piece of equipment or those directions of the device orpiece of equipment being translated or moved.

Finally, terms of degree such as “substantially”, “about” and“approximately” as used herein mean the specified value or the specifiedvalue and a reasonable amount of deviation from the specified value(e.g., a deviation of up to ±0.1%, ±1%, ±5%, or ±10%, as such variationsare appropriate) such that the end result is not significantly ormaterially changed. For example, “about 1.0 cm” can be interpreted tomean “1.0 cm” or between “0.9 cm and 1.1 cm.” When terms of degree suchas “about” or “approximately” are used to refer to numbers or valuesthat are part of a range, the term can be used to modify both theminimum and maximum numbers or values.

This disclosure is not intended to be limited to the scope of theparticular forms set forth, but is intended to cover alternatives,modifications, and equivalents of the variations or embodimentsdescribed herein. Further, the scope of the disclosure fully encompassesother variations or embodiments that may become obvious to those skilledin the art in view of this disclosure.

1.-74. (c4anceled)
 75. An accommodating intraocular lens, comprising: anoptic portion; a peripheral portion coupled to the optic portion;wherein at least one of the optic portion and the peripheral portion ismade in part of a composite material comprising an energy absorbingconstituent and a plurality of expandable components, and wherein a basepower of the optic portion is configured to change in response to anexternal energy directed at the composite material.
 76. Theaccommodating intraocular lens of claim 75, wherein the expandablecomponents are expandable microspheres, wherein each of the expandablemicrospheres comprises a blowing agent contained within a thermoplasticshell.
 77. The accommodating intraocular lens of claim 76, wherein adiameter of at least one of the expandable microspheres is configured toincrease between about 2× to about 4× in response to the external energydirected at the composite material.
 78. The accommodating intraocularlens of claim 75, wherein the energy absorbing constituent is an energyabsorbing colorant.
 79. The accommodating intraocular lens of claim 78,wherein the energy absorbing colorant is an azo dye.
 80. Theaccommodating intraocular lens of claim 78, wherein the energy absorbingcolorant is graphitized carbon black.
 81. The accommodating intraocularlens of claim 78, wherein the at least one of the optic portion and theperipheral portion is made in part of a first composite material and asecond composite material, wherein the first composite materialcomprises a first energy absorbing colorant and the second compositematerial comprises a second energy absorbing colorant, wherein a colorof the first energy absorbing colorant is different from a color of thesecond energy absorbing colorant.
 82. The accommodating intraocular lensof claim 75, wherein at least one of the optic portion and theperipheral portion is made in part of a cross-linked copolymercomprising a copolymer blend, and wherein the composite material is madein part of the copolymer blend.
 83. The accommodating intraocular lensof claim 82, wherein the copolymer blend comprises an alkyl acrylate, afluoro-alkyl acrylate, and a phenyl-alkyl acrylate.
 84. Theaccommodating intraocular lens of claim 75, wherein the base power ofthe optic portion is configured to change between about ±0.05 D to about±0.5 D in response to a pulse of the external energy directed at thecomposite material.
 85. The accommodating intraocular lens of claim 75,wherein the base power of the optic portion is configured to change byup to ±5.0D in total.
 86. The accommodating intraocular lens of claim75, wherein the external energy is laser light having a wavelengthbetween about 488 nm to about 650 nm.
 87. The accommodating intraocularlens of claim 75, wherein the optic portion is made in part of thecomposite material, and wherein a cylindricity of an optical surface ofthe optic portion is configured to change in response to the externalenergy directed at the optic portion.
 88. The accommodating intraocularlens of claim 75, wherein the optic portion comprises an anteriorelement having an anterior optical surface and a posterior elementhaving a posterior optical surface.
 89. The accommodating intraocularlens of claim 88, wherein the composite material is located along afirst peripheral edge of the anterior element and along a secondperipheral edge of the anterior element diametrically opposed to thefirst peripheral edge, and wherein the cylindricity of the anterioroptical surface is configured to change in response to the externalenergy directed at the first peripheral edge and the second peripheraledge.
 90. The accommodating intraocular lens of claim 88, wherein thecomposite material is located along a first peripheral edge of theposterior element and along a second peripheral edge of the posteriorelement diametrically opposed to the first peripheral edge, and whereinthe cylindricity of the posterior optical surface is configured tochange in response to the external energy directed at the firstperipheral edge and the second peripheral edge.
 91. The accommodatingintraocular lens of claim 75, wherein the optic portion comprises ananterior element, a posterior element, and a fluid-filled optic chamberdefined therebetween, and wherein the anterior element is bonded oradhered circumferentially to the posterior element by an adhesive layerand wherein the adhesive layer comprises the composite material.
 92. Theaccommodating intraocular lens of claim 75, wherein the optic portioncomprises a fluid-filled optic chamber and the peripheral portioncomprises at least one haptic comprising a fluid-filled haptic fluidchamber in fluid communication with the optic chamber.
 93. Theaccommodating intraocular lens of claim 92, wherein the base power isconfigured to change in response to fluid displacement between the opticchamber and the haptic fluid chamber as a result of the external energydirected at the composite material.
 94. The accommodating intraocularlens of claim 92, wherein the base power is configured to change inresponse to a change in a volume of the haptic fluid chamber as a resultof the external energy directed at the composite material.
 95. Theaccommodating intraocular lens of claim 92, wherein the compositematerial is configured as a spacer extending radially from a hapticchamber wall, wherein the spacer is configured to expand in response tothe external energy directed at the spacer, and wherein expansion of thespacer decreases a volume of the haptic fluid chamber by pushing thehaptic against a capsular environment surrounding the accommodatinglens.
 96. The accommodating intraocular lens of claim 92, wherein thecomposite material is located partly within a haptic chamber wallsurrounding the haptic fluid chamber.
 97. The accommodating intraocularlens of claim 92, wherein the composite material is located at leastpartially within a channel formed along a radially inner wall of thehaptic, wherein a volume of the haptic fluid chamber is configured toexpand in response to the external energy directed at the compositematerial.
 98. The accommodating intraocular lens of claim 92, whereinthe composite material is located at least partly along a radiallyoutermost portion of a radially inner wall of the haptic, wherein avolume of the haptic fluid chamber is configured to decrease in responseto the external energy directed at the composite material.
 99. Theaccommodating intraocular lens of claim 98, wherein the compositematerial is configured to expand into the haptic fluid chamber inresponse to the external energy directed at the composite material. 100.An accommodating intraocular lens, comprising: an optic portion; and ahaptic coupled to the optic portion, wherein the haptic comprises afirst haptic portion and a second haptic portion, wherein the firsthaptic portion is made in part of a composite material comprising anenergy absorbing constituent and a plurality of expandable components,wherein the second haptic portion is made in part of the compositematerial, wherein a base power of the optic portion is configured toincrease in response to an external energy directed at the first hapticportion, and wherein the base power of the optic portion is configuredto decrease in response to the external energy directed at the secondhaptic portion.
 101. The accommodating intraocular lens of claim 100,wherein the optic portion comprises a fluid-filled optic fluid chamberand the haptic comprises a fluid-filled haptic fluid chamber in fluidcommunication with the optic fluid chamber.
 102. The accommodatingintraocular lens of claim 101, wherein the base power of the opticportion is configured to increase in response to the external energydirected at the first haptic portion as a result of fluid flowing fromthe haptic fluid chamber to the optic fluid chamber.
 103. Theaccommodating intraocular lens of claim 101, wherein the base power ofthe optic portion is configured to decrease in response to the externalenergy directed at the second haptic portion as a result of fluidflowing from the optic fluid chamber to the haptic fluid chamber. 104.The accommodating intraocular lens of claim 100, wherein the firsthaptic portion is made in part of a first composite material, whereinthe second haptic portion is made in part of a second compositematerial, wherein the first composite material comprises a first energyabsorbing constituent, wherein the second composite material comprises asecond energy absorbing constituent, and wherein a composition of thefirst energy absorbing constituent is different from a composition ofthe second energy absorbing constituent.
 105. The accommodatingintraocular lens of claim 100, wherein the first haptic portion isradially offset from the second haptic portion.
 106. A method ofadjusting an accommodating intraocular lens, comprising: adjusting abase power of the accommodating intraocular lens by directing anexternal energy at a composite material within at least one of an opticportion and a peripheral portion of the accommodating intraocular lens,wherein the composite material comprises an energy absorbing constituentand a plurality of expandable components.
 107. The method of claim 106,further comprising adjusting the base power of the accommodatingintraocular lens when the accommodating intraocular lens is implantedwithin an eye of a subject.
 108. The method of claim 106, furthercomprising adjusting the cylindricity of an optical surface of an opticportion the accommodating intraocular lens by directing an externalenergy at the composite material arranged at diametrically opposedperipheral edges of the optic portion.
 109. The method of claim 106,wherein the external energy is a laser light having a wavelength betweenabout 488 nm to about 650 nm
 110. The method of claim 106, furthercomprising adjusting the base power of the optic portion between about±0.05 D to about ±0.5 D by directing a pulse of the external energy atthe composite material.
 111. The method of claim 106, wherein the opticportion comprises a fluid-filled optic chamber and the peripheralportion comprises at least one haptic comprising a fluid-filled hapticfluid chamber in fluid communication with the optic chamber, wherein themethod further comprises directing the external energy at the compositematerial to displace fluid between the optic chamber and the hapticfluid chamber.
 112. The method of claim 106, further comprisingadjusting the base power of the accommodating intraocular lens bydirecting the external energy at the composite material to change avolume of the haptic fluid chamber.
 113. The method of claim 106,further comprising adjusting the base power of the accommodatingintraocular lens by directing the external energy at the compositematerial to change a volume of the optic fluid chamber.